MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-475-25
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	02/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2019-00396, 2029214-2019-00397.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of pipeline flex migration during a procedure.The patient was undergoing flow diversion treatment of a ruptured blister aneurysm in ophthalmic segment of internal carotid artery (ica).The aneurysm was reported to have a max diameter and a neck diameter of 2mm.The landing zone was 3.8mm distally and 4.3mm proximally.The anatomy was reported to have been normal in tortuosity.The pipeline and the accessory devices were prepared as indicated in the ifu.A continuous flush was used during the delivery of the devices.Using standard intervention techniques, access was gained to the aneurysm.The ped 475-25 was advanced into catheter until the distal marker of ped matched with distal marker of catheter.The entire system was dragged into the straight segment of m1 & started deploying the ped which deployed well.It was then decided to track the catheter over the delivery wire of ped to capture tip of the wire of ped.While pushing the catheter the deployed ped foreshortened distally and fallen down missing the neck of the aneurysm, as neck of the aneurysm was uncovered with ped.It was decided to place another ped to telescope the devices/ vessel.There were no reports of patient injury in association with this event.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8559717
• Report Number: 2029214-2019-00395
• Device Sequence Number: 11195510
• Product Code: OUT
• UDI-Device Identifier: 00836462015883
• UDI-Public: 00836462015883
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2019

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: 09/24/2021
• Device Model Number: PED-475-25
• Device Lot Number: A713518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR