MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-450-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.
Event or Problem Description
Medtronic received information that during treatment of a right internal carotid artery, the pipeline device did not open distally.The pipeline was removed and a new pipeline of the same size was deployed successfully.No patient injury was reported.The aneurysm was irregular in shape, max diameter was 4.77 mm x 3.7 mm.The neck width was 2.8 mm.The proximal landing zone was 4 mm and the distal was 4.45 mm.The patient had moderate vessel tortuosity and the pipeline was deployed on a curve.
Additional Manufacturer Narrative
The pipeline braid and pipeline flex pushwire were returned for evaluation.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline braid was observed to be fully open with both ends having slight fraying, and the middle section having no damages.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Pushwire was observed bent.No other anomalies were observed.Based on the analysis findings, reported event details, and customer photos, the clinical observation could not be confirmed.We unable to definitively determine the cause for the reported experience.However, it is possible that the damaged braid and the patient¿s vessel anatomy (the bend) may have contributed to the reported issue.The pipeline flex pushwire was observed to be damaged.However, the cause for the damages could not be determined.Our instructions for use (ifu) indicates to: ¿begin to deliver the pipeline flex embolization device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.".
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo; irvine CA 92618
• MDR Report Key: 6527123
• Report Number: 2029214-2017-00590
• Device Sequence Number: 1641589
• Product Code: OUT
• UDI-Device Identifier: 00847536016477
• UDI-Public: 00847536016477
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2019
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: A262805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided; 05/17/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/13/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 123