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

Model Number PED-500-25

Device Problems Physical Resistance (2578); Activation Failure (3270)

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

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; therefore, the reported event could not be confirmed.A supplemental report will be submitted once the device is returned.

Event Description

Medtronic received information that during treatment of an aneurysm located in the cavernous segment of the ica, the pipeline did not open distally as the patient had severe vessel tortuosity.There was also a report of movement during placement, moderate difficult placement/positioning.It was reported that the patient had a proximal loop in ica and a torturous posterior and anterior genuine of ica.During advancement of the pipeline through the marksman at the cavernous segment, the tip of the system at the distal marker appeared to be kinked at a 45 degree angle.This kink was present as the device was advanced up to the m1 segment.During initial delivery the delivery wire at the distal marker appeared to be kinked and the pipeline device was opening in a trumpet shape.There was resistance encountered during advancement of the pipeline within the distal segment of the marksman.After resheathing multiple times, the device exhibited the same trumpet shape and the physician decided to abort the procedure.The device was removed by retracting the marksman and pipeline into the guide catheter and removed from the patient.No patient injury was reported.Post angiography result was normal.The aneurysm was unruptured and saccular.The max diameter was 13 mm and the neck diameter was 10 mm.The distal landing zone was 4.9 mm and the proximal was 4.2 mm.More than 50 percent of the device was deployed, and the device was resheathed less than or equal to 2 times.

Manufacturer Narrative

Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine 92618 ; 9496801224
• MDR Report Key: 6139457
• MDR Text Key: 61302276
• Report Number: 2029214-2016-01081
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: PED-500-25
• Device Lot Number: A294091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR