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

Model Number PED-500-20

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  malfunction  

Event Description

Stent introduced into patient did not deploy correctly and had to be recaptured.The distal end of the stent would not expand.A second attempt did not remedy the situation.A new stent had to be opened and it did work correctly.Potential for harm was present, but no harm noted.

• Brand Name: PIPELINE FLEX
• 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: 6383419
• MDR Text Key: 69220148
• Report Number: 6383419
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: A254080
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR