MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-18 for PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[183955500]
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183955501]
Ajnr am j neuroradiol. 2020 jan;41(1):140-146. Doi: 10. 3174/ajnr. A6343. Epub 2020 jan 2. ? Reduced activity of von willebrand factor after flow-diverting stent implantation for intracranial aneurysms: a link to acquired von willebrand disease?? I. Oran, c. Cinar, h. Bozkaya, m. Parildar, and s. Duman 2 clinical complications - first, 1 patient from the reduced vwf group with 2 aneurysms at the basilar artery fenestration and right mca bifurcation experienced dysphasia 10 days after treatment. Mr imaging showed right-sided insular cortex ischemia. At 3months, the dysphasia had resolved completely, and both aneurysms were occluded according to cta. Second, 1 patient from the reduced vwf group with 3 aneurysms at the anterior communicating artery and right and left mca bifurcation experienced rupture of a large (18-mm maximum diameter) anterior communicating artery aneurysm into the ventricular system 4 weeks after treatment, which subsequently resulted in death. For anatomic reasons, preventive coiling before fds implantation was not used for this relatively large aneurysm. No other clinical complications were observed during the 3-month follow-up period. This study is the first to show laboratory evidence of reduced vwf activity in approximately 41% of our study population after fds implantation for the treatment of intracranial aneurysms. Reduced vwf activity was best predicted by the morphologic index and volume of the aneurysm, with cutoff values of 4343 and 256, respectively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00254 |
| MDR Report Key | 9849469 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-18 |
| 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 | MGR. 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 | 2020-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-18 |