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

Model Number	PED-425-14
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex was returned.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 pipeline flex braid appeared fully opened and no damage.No bend found on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing marker or with the proximal bumper.No damage found with the returned catheter.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have failure to open as pipeline flex braid was found fully opened and no damage.Mdrs related to this event: 2029214-2019-01173, 2029214-2019-01174, 2029214-2019-01175.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of pipeline flex incomplete opening during a procedure.The patient was undergoing treatment of a left ica, unruptured, saccular aneurysm.The distal landing zone was 3.7mm and the proximal was 4.1mm.The vessel tortuosity was minimal.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed per the ifu.It was reported that during the procedure, a pipeline flex was attempted to be placed and did not open in the middle and proximal sections.The device was resheathed with the microcatheter and removed.There were no reports of 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: 9386397
• Report Number: 2029214-2019-01174
• Device Sequence Number: 469499
• Product Code: OUT
• UDI-Device Identifier: 00847536016118
• UDI-Public: 00847536016118
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/27/2019

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: 05/21/2020
• Device Model Number: PED-425-14
• Device Lot Number: A463686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR