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

Model Number FA-77450-18

Device Problems Detachment Of Device Component (1104); Delamination (2904)

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

Event Date 03/17/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information that during a treatment of a right internal carotid artery giant partially thrombosed aneurysm with a pipeline embolization device and coils, the physician reported that the green coating in the delivery wire of the pipeline delaminated and detached from pipeline pushwire.The pipeline device was implanted successfully.No patient injury was reported as a result of this procedure.

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no quality issues were noted.The pipeline delivery system (pushwire) and microcatheter were returned for evaluation without the pipeline.Per the initial report, the pipeline was implanted in the patient.Evaluation is still in progress and results pending completion of evaluation.A supplemental mdr wil be completed once the device evaluation results become available.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• 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 ; 9496801224
• MDR Report Key: 4700130
• MDR Text Key: 18926424
• Report Number: 2029214-2015-00386
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2016
• Device Model Number: FA-77450-18
• Device Lot Number: 9786527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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: 78 YR