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

Catalog Number FA-77375-14

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 02/16/2015

Event Type  No Answer Provided  

Event Description

During coil and embolization treatment of an aneurysm, the device was noted to be delaminating during insertion.The device was removed prior to placement, and a separate device was used in lieu of the defective device for patient safety purposes.

• Brand Name: PIPELINE EMBOLIZATION
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS INC, DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 4767815
• MDR Text Key: 15834361
• Report Number: 4767815
• Device Sequence Number: 1
• Product Code: OUT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Physician
• Device Catalogue Number: FA-77375-14
• Device Lot Number: 9839842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR