|
Model Number NV UNK PIPELINE |
Device Problems
Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Intracranial Hemorrhage (1891); Nerve Damage (1979); Paresis (1998); Obstruction/Occlusion (2422); Syncope/Fainting (4411); Thrombosis/Thrombus (4440)
|
Event Date 11/03/2022 |
Event Type
Injury
|
Event Description
|
Tong x, he z, han m, feng x, duan c, liu a.Flow diversion treatment for giant intracranial serpentine aneurysms.Frontiers in aging neuroscience.2022;14:988411.Doi:10.3389/fnagi.2022.988411 medtronic literature review found reported of death, subarachnoid hemorrhage, thrombotic events leading to progressive right hemiparesis, right abducens nerve palsy, and loss of consciousness, and parent vessel occlusion in association with pipeline flow diverter treatment.The purpose of this article was to determine the efficacy of using flow diversion in treating great serpentine aneurysms.The authors reviewed 13 cases of patients treated for great serpentine aneurysms using flow diversion.Of the 13 patients, the average age was 60 years, 2 were female and 11 were male.Presenting symptoms were headache, hemiparesis, subarachnoid hemorrhage (sah), blurred vision, and loss of consciousness.The article does state one event with a technical issue during the use of the pipeline.In the article it states "however, other fd devices cannot be successfully placed owing to the extremely twisted morphology of the parent vessel." in addition, the o'kelly- marotta scale showed grades b-d in 72.7% of patients and a good prognosis with a mrs score of 0-2 in 66.7% of patients.The following intra- or post-procedural outcomes were noted: -one patient with bilateral internal carotid artery (ica) great serpentine aneurysms treated with a flow diverter device developed b ilateral ica occlusion and died after 5years.-one patient refused to take antiplatelet medication and died from an ischemic stroke -five postoperative complications a.Subarachnoid hemorrhage leading to death in the hospital b.Progressive right hemiparesis with loss of consciousness from a thrombotic event c.Progressive loss of consciousness from a thrombotic event d.Right hemiparesis from a thrombotic event e.Right abducens nerve palsy from a thrombotic event -parent artery occlusion found in 3 patients.
|
|
Manufacturer Narrative
|
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|