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

Model Number	PED-300-12
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is being reported based on the analysis findings.Analysis of the pipeline (model: ped-300-12 lot: a655389) found that the distal and proximal dps restraints were intact when compared to the drawing.The dps sleeves and tip coil were found damaged.The hypotube appeared to be intact and with no stretching and the ptfe shrink tubing was found still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.No other damages or anomalies were found with the devices.Based on the analysis findings, the customer report of ¿pushwire kink/damage¿ was confirmed, however, the cause could not be determined.The dps sleeves and the tip coil were found damaged.Possible causes of failure are resistance/stuck during delivery, devices not hydrated per ifu, patient anatomy, or high force delivery.Customer reported patient vessel tortuosity as minimal, devices were prepared as per ifu, and no resistance was noted.As the braid and phenom-27 micro catheter were not returned for analysis, any contribution of the braid and phenom-27 micro catheter towards the ¿pushwire kink/damage¿ could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pipeline pushwire was deformed during delivery.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm with a max diameter of 3mm and a 2mm neck diameter.It was noted the patient's vessel tortuosity was minimal.It was unknown if dual antiplatelet therapy (dapt) was administered.It was reported that when the pipeline was advanced through the microcatheter, the distal tip was visualized fluoroscopically and the physician noted that the wire appeared to be deformed.When the device was removed from the microcatheter, the distal tip was not straight.The pushwire did not appear to be damaged during preparation and delivery; however, it appeared to have been damaged prior to delivery.No friction at all was noted.A replacement was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a phenom plus, phenom 27, synchro ii, target nano 2 coils.

• 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: 10972013
• Report Number: 2029214-2020-01253
• Device Sequence Number: 4214518
• Product Code: OUT
• UDI-Device Identifier: 00847536014732
• UDI-Public: 00847536014732
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 06/03/2021
• Device Model Number: PED-300-12
• Device Catalogue Number: PED-300-12
• Device Lot Number: A655389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR