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

Model Number	PED-375-14
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex has not been returned for evaluation.The reported event could not be confirmed.An event cause could not be conclusively determined from the reported information.
Event or Problem Description
Medtronic received report that a pipeline flex did not open on the distal end during a procedure.
Additional Manufacturer Narrative
Sex - additional information.Event description - additional information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional event information: the patient was undergoing treatment for an unruptured aneurysm in the ophthalmic artery.The vessel was reportedly tortuous.The devices were prepared as indicated in the ifu.It was reported that approximately 7-8 mm of the pipeline flex was pushed out of the microcatheter; the distal end did not open.The physician attempted to bump the device using the microcatheter, but was not successful in opening it.The pipeline flex was withdrawn from the patient.Afterward, a new pipeline flex was implanted without reported issues.There were no reports of patient injury in connection with this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the pipeline flex pushwire was returned for evaluation without the braid.As received, the pipeline flex pushwire was observed to be stuck within the catheter.The pipeline flex pushwire could not be pushed forward or pulled back.For further examination, the catheter was dissected at several locations to remove the pipeline flex pushwire.No damage was found on the tip coil, dps sleeves, resheathing pad, and distal hypotube.Based on the analysis findings and the reported event details, the report of pipeline flex failure to open on the distal end could not be confirmed.The cause for the reported experience could not be determined as the pipeline flex braid was not returned.It is possible that the patient¿s ¿tortuous¿ vessel anatomy may have contributed to the reported issue.All products are 100% inspected for damage and irregularities during manufacture.The pipeline flex instructions for use provide the following guidance: do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6495621
• Report Number: 2029214-2017-00451
• Device Sequence Number: 16554522
• Product Code: OUT
• UDI-Device Identifier: 00847536015579
• UDI-Public: 00847536015579
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 03/20/2017

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: 01/26/2020
• Device Model Number: PED-375-14
• Device Lot Number: A405965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided; 07/05/2017; 07/05/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/22/2017; 07/21/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1