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

Model Number PED-500-35

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

Patient Problems Aneurysm (1708); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/03/2019

Event Type  Death  

Event Description

The patient harbored a giant aneurysm and it was pipelined and she did well post-op and then the aneurysm bled two days later and she passed away.

• Brand Name: PIPELINE
• 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: 9811043
• MDR Text Key: 182730302
• Report Number: 9811043
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PED-500-35
• Device Lot Number: A827599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Date Report to Manufacturer: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29930 DA