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

Model Number	PED-450-16
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex pushwire was returned.The pipeline flex pushwire appeared to be separated into two segments.There was no pipeline flex braid returned with the devices as it was implanted.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The pushwire appeared to be separated at 107.0cm from the proximal end.The ptfe shrink tubing was found to be damaged and peeled off near the broken ends.Bend found on the pushwire at 16.0cm from the proximal end.Based on the returned devices, the pipeline flex and phenom catheter were confirmed to have pushwire separation and resistance during delivery.The fracture surface exhibits dimple features consistent with tensile overload failure mechanism.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that pipeline flex pushwire separated.The pipeline flex device was successfully deployed with good wall apposition and good neck coverage; upon retrieving the delivery wire of the pipeline device, it was noticed there was no movement of the tip coil; it was attempted again to retrieve the wire.The entire delivery system and catheter were removed, and the delivery wire was noticed to have broken inside of the microcatheter.The device was prepared and used per the instructions for use (ifu).The catheter was flushed as per the ifu.The tortuosity was moderate and appeared to be a slightly tougher to advance the device more so than normal.This event occurred during the treatment of a left ophthalmic, internal carotid artery (ica), unruptured, amorphous, aneurysm.The max diameter was 7mm and neck width of 5mm.The distal landing zone was 3.96mm and the proximal was 4.43mm.

• 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: 9333604
• Report Number: 2029214-2019-01136
• Device Sequence Number: 16705143
• Product Code: OUT
• UDI-Device Identifier: 00847536016415
• UDI-Public: 00847536016415
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2019

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: 05/01/2022
• Device Model Number: PED-450-16
• Device Lot Number: A824262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR