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

Model Number PED-500-16

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Event Description

Distal end of the stent looked ragged and would not open.When trying to remove it, broke off in the catheter.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8050587
• MDR Text Key: 126555302
• Report Number: 8050587
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019669
• UDI-Public: (01)00847536019669
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-500-16
• Device Catalogue Number: PED-500-16
• Device Lot Number: A417212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA