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

Model Number	PED-425-16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The proximal segment of the pushwire and pipeline flex braid were returned.The distal segment of the pushwire along with the tip coil, sleeves, resheathing marker, resheathing pad and proximal bumper were not returned.The pushwire found to be separated at the distal hypotube.There was evidence of corrosion around the broken end.The distal hypotube was slightly stretched with the ptfe shrink tubing still intact.The outer jacket on the distal hyotube was slightly pulled back from the broken end.No bend observed on the pushwire.No other anomalies were observed.The broken end of the pushwire was sent out for scanning electron microscope (sem) and energy dispersive x-ray spectroscopy (eds) analyses.Based on the returned device, the pipeline flex was confirmed to have pushwire separation.The returned pipeline flex pushwire was found to be damaged and separated.Per the sem/eds results, the fracture surface exhibits corrosion damage that obscured the original fracture features.No definitive conclusions can be provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that reported pipeline flex pushwire broke during the procedure.The patient was undergoing embolization treatment for a small unruptured amorphous right ophthalmic artery aneurysm.Measuring 3mmx6mm, landing zone distal 3.3mm proximal 3.9mm.The vessel was observed minimal tortuous.It was reported that the pipeline was 40% deployed, it was fully open distal.When stopped to take a angio and when the physician went to capture the device to move it down about a mm he felt a pop.That¿s when the pusher came detached from the pipeline wire.There were not any patient symptoms or complications associated with this event.No patient injury was reported.The partially deployed pipeline was captured by running up the medtronic guidecatheter over it and removing the entire system.

• 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: 9316379
• Report Number: 2029214-2019-01127
• Device Sequence Number: 16705219
• Product Code: OUT
• UDI-Device Identifier: 00847536016149
• UDI-Public: 00847536016149
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: 06/28/2022
• Device Model Number: PED-425-16
• Device Lot Number: A856747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 68