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

Model Number	PED-425-25
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline device has not been returned for evaluation.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that pipeline flex embolization device felt resistance inside the marksman catheter and did not open.The patient underwent embolization treatment for an intracranial aneurysm.The vessel was observed moderately tortuous.It was reported that after the marksman150 microcatheter was put in place, the doctor was introduced into 4.25-25 pipeline flex.After ped entered the marksman and pushed a distance, it was found that there was very great resistance, very difficult to push the ped out of the marksman microcatheter.After the release of the tip end, it was found that the ped stent cannot continue to push out the microcatheter, the retracement of the marksman microcatheter all released ped, found that the ped was not opened well, the multi-stage was not attached to the vessel wall.Surgery was performed after expansion using the hyperform balloon.The pipeline was implanted within the intended location.There resistance within the marksman catheter caused damage to the catheter body and pipeline.There were no patient symptoms or complications associated with this event.No patient injury was reported.Reported device and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated per the ifu.This event occurred during the treatment of multiple aneurysms in the ophthalmic artery segment: aneurysm 1: aneurysm diameter: 5.39mm; aneurysm diameter: 3.96mm; aneurysm 2: aneurysm diameter: 2.38mm; aneurysm diameter: 1.90mm.

• 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: 8461741
• Report Number: 2029214-2019-00252
• Device Sequence Number: 3013410
• Product Code: OUT
• UDI-Device Identifier: 00847536016231
• UDI-Public: 00847536016231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 04/30/2021
• Device Model Number: PED-425-25
• Device Lot Number: A638328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR