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

Model Number PED-350-14

Device Problem Break (1069)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The 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 Description

Medtronic received information that during embolization treatment, the pushwire proximal tip broken during removing of the pushwire after pipeline implanted.The patient underwent embolization treatment of unruptured saccular aneurysm located in internal carotid artery.It was reported that pipeline deployed per the ifu, microcatheter re-advanced post deployment of pipelined and pushwire recaptured.15mm tip wire broke off while removing and remained in the proximal catheter.No patient injury was reported.

Manufacturer Narrative

The device was returned for evaluation and the clinical observation was confirmed.As received, the pushwire was found separated into two segments.The distal broken segment was found stuck inside distal segment of the microcatheter.The proximal segment of the pushwire was found outside of the catheter.During evaluation, the catheter was then cut to remove the distal broken segment of the pipeline flex pushwire.The pipeline flex braid was not returned as it was implanted in the patient.Additionally, the pushwire found bent at the proximal end.The broken end of the pipeline flex pushwire was then sent out for scanning electron microscopy (sem) analysis.Based on the analysis findings, the event description and the sem analysis; the failure mode for the ¿pushwire separation¿ is tensile overload.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.All products are 100% inspected for damage and irregularities during manufacture.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, CA 92618 ; 9498373700
• MDR Report Key: 7492562
• MDR Text Key: 107566639
• Report Number: 2029214-2018-00375
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Model Number: PED-350-14
• Device Lot Number: A407059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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