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

Model Number PED-425-16

Device Problem Migration (4003)

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

Event Date 11/08/2018

Event Type  malfunction  

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 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
• 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: 8129156
• MDR Text Key: 129465285
• Report Number: 2029214-2018-01018
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016149
• UDI-Public: 00847536016149
• 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
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: PED-425-16
• Device Lot Number: A678861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 39 YR