MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-17 for PIPELINE NV UNK PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[183645627]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183645628]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00240 |
| MDR Report Key | 9838829 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIPELINE |
| Generic Name | INTRACRANIAL ANEURYSM FLOW DIVERTER |
| Product Code | OUT |
| Date Received | 2020-03-17 |
| Model Number | NV UNK PIPELINE |
| Catalog Number | NV UNK PIPELINE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-17 |