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

Model Number FA-71450-25

Device Problems Flaked (1246); Delamination (2904)

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

Event Date 02/02/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information regarding an incident with one of its products.Treatment of an unruptured saccular aneurysm located in the petrous segment of the left ica (internal carotid artery).During the procedure, it was reported the physician noticed lining (bluish material) from the pushwire peeling off into the rotating hemostatic valve (rhv) of a pipeline (4.5mm x 25mm) device.The pipeline was successfully implanted inside the patient.During the same procedure, another pipeline (5mm x 35mm) could not be opened on the proximal segment and it was removed from the patient with a gooseneck snare.Post procedural angiogram demonstrated complete occlusion of the aneurysm.(b)(4).

Manufacturer Narrative

The device has been received and the evaluation is in progress.A follow-up report will be submitted once the evaluation is complete.The lot history record review of the reported lot number showed no discrepancies that might have contributed to the reported experience.(b)(4).

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed.The pipeline delivery system (pushwire) was returned for evaluation without the rhv valve, torque device and catheter.Per the initial report, the pipeline was implanted in the patient.The capture coil appeared to be damaged.No bends were observed on the returned pushwire.The coating of the entire pushwire length was examined under the video inspection system (30x magnification) for coating integrity.The ptfe coating on the pushwire was found scraped at 3 locations.The ptfe coating was also found on the capture coil.No other complaints have been reported against the lot number.Based on the above findings, the customer's report was confirmed.The coating appeared to be damaged by mechanical scraping and abrasion or force.The capture coil was also damaged.However, the cause for damage could not be determined.All products are 100% inspected for damage and irregularities during manufacture.

• 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: 4581396
• MDR Text Key: 5453455
• Report Number: 2029214-2015-00235
• 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,Followup
• Report Date: 02/24/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2017
• Device Model Number: FA-71450-25
• Device Lot Number: 9911779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 03/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2014
• 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: 64 YR