MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER
|
Back to Search Results |
|
Model Number NV UNK PIPELINE |
Device Problem
No Apparent Adverse Event (3189)
|
Patient Problem
Death (1802)
|
Event Date 04/15/2015 |
Event Type
Death
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Meyers pm, coon al, kan pt, wakhloo ak, hanel ra.Scent trial. stroke.2019;50(6):1473-1479.Doi: 10.1161/strokeaha.118.024135.The literature article was pertaining to a competitor "surpass" stent, the allegations against the pipeline device were for patients treated alongside the competitor device.Medtronic received a report that one patient, who was a surpass treatment failure and received a pipeline device instead, had a hemorrhagic stroke and died 8 days following treatment.In another case, a pipeline device was placed after a surpass device was implanted but without complete coverage of the aneurysm neck.
|
|
Manufacturer Narrative
|
A1-a4- patient information - additional information.B3: date of event - additional information.B5: event description - additional information.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.
|
|
Event Description
|
Medtronic received additional information received regarding hemorrhagic stroke: loss of consciousness.Hemorrhagic stroke (intraparenchymal) in the treated vascular territory, distal to pipeline device placement 8 days following pipeline deployment.Platelet inhibition was known be increased.The patient died.Event started on (b)(6) 2015 (8 days from device implantation) and stop date of event is (b)(6) 2015 model and lot number of the device not available.
|
|
Search Alerts/Recalls
|
|
|