MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Ischemia (1942); Dysphasia (2195)

Event Type  Death  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9849469
• MDR Text Key: 183955500
• Report Number: 2029214-2020-00254
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death