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

Model Number	PED-425-16
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex device will not be returned for analysis as remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during treatment, the pipeline flex (ped) device migrated proximal after placement.The patient was undergoing flow diversion of a small unruptured saccular aneurysm located in left internal carotid artery, measuring 7mmx5mm, landing zone distal 3mm, proximal 4mm.The vessel was observed as severely tortuous.It was reported that ped was delivered without incident.The proximal end was lazy open; however, it opened once fully deployed.A non-medtronic guidewire was used to smooth expand the ped at the proximal end.The ped looked fully opened and apposed.When the distal end was released, the device was alleged to have migrated proximally.The ped is now partially crossing the neck but not fully covering the neck of the aneurysm.Multiple times were made to cross the ped with the idea to delivery another ped distal to the first.However, the wire was unable to navigate distally.The patient will be retreated.The patient was reported to be asymptomatic and no other complications were reported.The patient was dual antiplatelet treatment.The pru level was 130.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8129156
• Report Number: 2029214-2018-01018
• Device Sequence Number: 267945
• Product Code: OUT
• UDI-Device Identifier: 00847536016149
• UDI-Public: 00847536016149
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: PED-425-16
• Device Lot Number: A678861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR