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

Model Number PED-375-12

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

The lot history records of the reported lot numbers have been reviewed and no quality issues were noted.The pushwire were returned for evaluation without the pipeline as it was implanted in the patient.The pushwire appeared to be detached at hypotube proximal wire weld (sample #2) and broken at the distal hypotube (sample # 1).The distal hypotube was found to be stretched.Per initial report, all broken segments were removed from the patient.Both samples of the pushwire were sent out for sem (scanning electron microscope) and eds (energy dispersive x-ray spectrum) analysis.No other anomalies were observed.Based on the above findings, sem and eds analysis, the customer's complaints were confirmed.The broken end of the pushwire (sample # 1) suggests ductile overload failure mechanism.In regards to the pushwire detached at the hypotube (sample # 2), it is likely a tensile overload that exceeded the strength of the solder joint.These damages likely occurred subsequent to the movement of the pushwire against the reported resistance.All products are 100% inspected for damage and irregularities during manufacture.

Event Description

Medtronic (covidien) received report that a pipeline flex pushwire detached during treatment of a right ophthalmic artery aneurysm.The patient's anatomy was of normal tortuosity.Heparinized saline flush was used during the procedure.The pipeline flex was 40-50% deployed across the neck of the aneurysm and partially around the carotid siphon when the physician decided to resheath the pipeline for better positioning.The microcatheter was stabilized and retrieval was attempted by pulling the pushwire.The physician noted there was a small amount of resistance during pulling, but no recovery of the device.After a few attempts, the pushwire was moving freely in the microcatheter while all of the markers remained in place under fluoroscopy indicating the delivery system had detached.The physician decided to deliver the pipeline flex fully by pushing the wire.The pipeline flex was fully deployed, but was not in the proper position; it was proximal to the aneurysm, partially over the aneurysm neck.The microcatheter was advanced through the pipeline flex braid to the detached distal delivery wire, which was retrieved.The delivery wire, microcatheter and guide catheter were all extracted simultaneously.Only the pipeline flex braid remains in the patient; all broken segments were removed.Upon inspection outside of the patient, it was observed that the proximal marker was detached from the hypotube pushwire.A second ped was placed across the aneurysm without incident.No patient injury was reported as a result of this procedure.

• Brand Name: PIPELINE FLEX 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 ; 9498373700
• MDR Report Key: 5025619
• MDR Text Key: 24817010
• Report Number: 2029214-2015-00918
• 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
• Report Date: 08/06/2015

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: 03/05/2018
• Device Model Number: PED-375-12
• Device Lot Number: A069400
• Other Device ID Number: 00836462015326180305A069400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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: 44 YR