Reports for Product Code OBA
Additional Manufacturer Narrative: The device involved in the event will not been returned for evaluation as it was consumed in the event; therefore, the event cause could not be determined. For apollo microcatheter, reference mdr# 2029214-2018-00858. If information is provided in the future, a supplemental report will be issued.
Description of Event or Problem: Medtronic received information that the medtronic flow directed microcatheter ruptured in the middle of the microcatheter (but remained intact) while the medtronic liquid embolic was being injected through it at a rate of 0.05 ml/min continuously without pause. There was no reflux. A minor amount of medtronic liquid embolic leaked...show all
Description of Event or Problem: Citation: katrin van loock et al. Microsurgical removal of onyx hd-500 from an aneurysm for relief of brainstem compression. J neurosurg. 2010 oct;113(4):770-3. Doi: 10.3171/2009.10.jns09668. The following report was received through review of literature: magnetic resonance imaging revealed an onyx mass was substantially compressing the right cerebral peduncle 5 years...show all
Additional Manufacturer Narrative: Http://www.ncbi.nlm.nih.gov/pubmed/19895204. The onyx was not returned for evaluation as it was discarded. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post procedure and its cause was unknown. The lot history record review was...show all
Description of Event or Problem: (b)(4). The following report was received by medtronic (covidien) through review of literature: patient's ages ranged from 35-85 years with a mean age of 57. The following adverse events were experienced following the procedure using onyx hd-500 (ev3). Worsening of preexisting cranial neuropathies (oculomotor deficit) was found in two patients,...show all
Additional Manufacturer Narrative: (b)(4). This report was created to capture the serious injuries related to the onyx. The onyx will not be returned for evaluation as they were consumed in the events. Based on the reported information, there did not appear to have been any defects of the devices during use. The events...show all
Description of Event or Problem: Medtronic (covidien) received report that during a cerebral arteriovenous fistula / embolization, the scepter balloon catheter (terumo) got immobilized after injecting onyx and could not be removed from the patient. It seemed the onyx was adhered to the tip of the balloon catheter. The physician inflated the balloon of scepter...show all
Additional Manufacturer Narrative: The onyx will not be returned for evaluation as it was consumed in the event. Based on the reported information, there is no evidence suggesting that the onyx was defective, but rather a procedure related event. The lot history record of the reported lot number has been reviewed and no...show all
Description of Event or Problem: Simon et al. Use of intracranial stenting to secure unstable liquid embolic casts in wide neck sidewall intracranial aneurysms. Was published in operative neurosurgery. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: at the conclusion of the procedure, after...show all
Additional Manufacturer Narrative: Http://journals.lww.com/neurosurgery/fulltext/2011/08000/use_of_intracranial_stenting_to_secure_unstable.59.aspx. This report was created to captured complications reported for patient number two. The devices will not be returned for analysis as they were consumed in the event; therefore the event cause could not be determined. The lot history record review was not possible since the lot numbers were not...show all
Description of Event or Problem: Simon et al. Use of intracranial stenting to secure unstable liquid embolic casts in wide neck sidewall intracranial aneurysms was published in operative neurosurgery. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: in this patient, after microcatheter removal, a...show all
Additional Manufacturer Narrative: Http://journals.lww.com/neurosurgery/fulltext/2011/08000/use_of_intracranial_stenting_to_secure_unstable.59.aspx. This report was created to capture complications described for patient one. The devices will not be returned for analysis as they were consumed in the event; therefore the event cause could not be determined. The lot history record review was not possible since the lot numbers were not reported....show all
Description of Event or Problem: Simon et al. Use of intracranial stenting to secure unstable liquid embolic casts in wide neck sidewall intracranial aneurysms. Was published in operative neurosurgery. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: after the aneurysm was obliterated with onyx,...show all
Additional Manufacturer Narrative: Http://journals.lww.com/neurosurgery/fulltext/2011/08000/use_of_intracranial_stenting_to_secure_unstable.59.aspx. This report was created to captured complications reported for patient number three. The devices will not be returned for analysis as they were consumed in the event; therefore the event cause could not be determined. The lot history record review was not possible since the lot numbers were not...show all
Description of Event or Problem: Simon et al. Use of intracranial stenting to secure unstable liquid embolic casts in wide neck sidewall intracranial aneurysms. Neurosurgery 66 [ons suppl 1]:ons92-ons98, 2010. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: a patient with a smaller ventral...show all
Additional Manufacturer Narrative: Http://journals.lww.com/neurosurgery/fulltext/2011/08000/use_of_intracranial_stenting_to_secure_unstable.59.aspx. This report was created to capture complications reported for patient number four. The lot history record review was not possible since the lot numbers were not reported. The devices will not be returned for analysis as they were consumed in the event; therefore the cause could not be determined....show all
Description of Event or Problem: Citation: ronie peske et al. Evaluation of onyx hd-500 embolic system in the treatment of 84 wide neck intracranial aneurysms. Neurosurgery vol. 64 number 5. May 2009. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: sixty- nine patients with...show all
Additional Manufacturer Narrative: Http://www.ncbi.nlm.nih.gov/pubmed/19404128. The lot history record review was not possible since the lot number was not reported. The onyx were not returned for analysis; therefore the event causes could not be determined. The events occurred in the patients during procedure and post procedure and their causes were unknown. (b)(4).
Description of Event or Problem: Citation: ronie peske et al. Evaluation of onyx hd-500 embolic system in the treatment of 84 wide neck intracranial aneurysms. Neurosurgery vol. 64 number 5. May 2009. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: clinical complications included two...show all
Additional Manufacturer Narrative: Http://www.ncbi.nlm.nih.gov/pubmed/19404128 this report was created to capture the death related to the onyx. The device was not returned for analysis, as it was consumed in the event; therefore the event cause could not be determined. The lot history record review was not possible since the lot numbers were not reported....show all
Description of Event or Problem: Citation: dr. Mr r reynolds. Hemorrhagic complications after prasugrel(effient) therapy for vascular neuro-interventional procedures. Published in j neurointervent surg on may 3, 2012. Medtronic (covidien) received information through literature review and the following event was captured as a result of the review: hemorrhage was observed in one patient treated with...show all
Additional Manufacturer Narrative: (b)(4). This report was created to capture complications related to the onyx. The onyx was not returned for evaluation as it was consumed in the event. The lot history record review was not possible since the lot number was not reported. Based on the reported information, there did not appear...show all
Description of Event or Problem: Citation: simon et al. Endovascular treatment of side wall aneurysms using a liquid embolic agent: a us single-center prospective trial. Neurosurgery 67:855-860, 2010 doi: 10.1227/01.neu.0000374772.22745.c3. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: during treatment of a left superior...show all
Additional Manufacturer Narrative: Article website: http://journals.lww.com/neurosurgery/abstract/2010/09000/endovascular_treatment_of_side_wall_aneurysms.37.aspx. The lot history record review was not possible since the lot numbers were not reported. The onyx was not returned for analysis as they were consumed in the event; therefore, the event causes could not be determined. (b)(4).
Additional Manufacturer Narrative: Article website: http://link.springer.com/article/10.1007%2fs00234-005-0007-6. The onyx will not be returned for evaluation as they were consumed in the events. The lot history record review was not possible since the lot numbers were not reported. Based on the reported information, there did not appear to have been any defect of the devices...show all
Additional Manufacturer Narrative: Common device name: polymerizing, neurovascular embolization material. Procode: oba. Pma h060003. Reference (b)(4).
Description of Event or Problem: Citation: h. Saruhan cekirge et al. Late angiographic and clinical follow-up results of 100 consecutive aneurysms treated with onyx recontruction: larges single center experience. Neuroradiology (2006) 48: medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: a total of 100...show all
Description of Event or Problem: Information received from the article: ashour et al. Onyx hd-500 for embolization of cerebral aneurysms. Neurological research. 2014 vol 36 no 4. Treatment of an aneurysm. It was reported that during one embolization procedure, onyx was seen herniating proximally into the lumen of the parent artery and the patient suffered...show all
Additional Manufacturer Narrative: The report was created to capture the complication caused by the device migration. All the information was received from the article: ashour et al. Onyx hd-500 for embolization of cerebral aneurysms. Neurological research. 2014 vol 36 no 4. (b)(4).
Description of Event or Problem: Information received from the article: johnson et al. Optic pathway infarct after onyx hd 500 aneurysm embolization: visual pathway ischemia from superior hypophyseal artery occlusion. J neurointervent surg 2014;6:e47. Treatment of an incidentally discovered small wide necked aneurysm measuring 7mm located in the superior hypophyseal segment of the left ica...show all
Additional Manufacturer Narrative: The report was created to capture the post procedure complication that occurred for the patient. All the information was received from the article: johnson et al. Optic pathway infarct after onyx hd 500 aneurysm embolization: visual pathway ischemia from superior hypophyseal artery occlusion. J neurointervent surg 2014;6:e47. (b)(4).