MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-400-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex device has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that during treatment of aneurysm location in the internal carotid (ic) c3, saccular shape, unruptured, 8mm neck width, landing zone vessel diameter 3mm distal 4mm proximal.The size of aneurysm was 13 mm, pipeline flex device did not open during a procedure.It was reported that the patient was treated with one medtronic flow diverter; however, it did not cover the neck completely.The treating physician decided to place an additional flow diverter.The reported pipeline was selected, however, this device failed to deploy (open distally).The device was resheathed 4 times or more but still the distal end of the flow diverter did not open.The wall apposition became poor resulting fixation failure of the flow diverter.The protective sleeve was opened, but the pipeline would still did not deploy.The anatomy was severe and small in diameter.The patient is currently being monitored.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8085447
• Report Number: 2029214-2018-00954
• Device Sequence Number: 11167749
• Product Code: OUT
• UDI-Device Identifier: 00847536015876
• UDI-Public: 00847536015876
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2021
• Device Model Number: PED-400-16
• Device Lot Number: A618628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1