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

Model Number	PED-475-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the pipeline 5.00mm x 35mm would not open completely in an extremely acute angle anterior genu distal to the aneurysm.It was noted that the device failed to open 6-8mm from the distal end in the anterior genu.Not happy with apposition in the anterior genu, the physician removed the pipeline 5.00mm x 35mm from the patient and attempted with the pipeline 4.75mm x 30mm: however, the pipeline 4.75mm x 30mm behaved the same in the extremely tortuous genu.The pipeline 4.75mm x 30mm was removed from the patient, and then the physician successfully deployed the shorter pipeline 4.50mm x 20mm landing just proximal to the anterior genu.It was stated that the distal section of the pipelines were positioned in a bend, and less than 50% of both pipelines had been deploy when it failed to open.Both pipelines were resheathed more than 2 times.There were no additional steps or other devices required to open the pipelines.Both pipelines were resheathed and removed with the microcatheter.The patient was undergoing surgery to treat an unruptured, saccular aneurysm located at the right cavernous with a max diameter of 16mm and a neck diameter of 4-5mm.The distal l anding zone was 3.8mm, and the proximal landing zone was 4.71mm.It was noted the vessel tortuosity was severe.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure was excellent, and the patient was doing well.It was noted t hat pru level was given as the facility uses teg and not verify now.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.

• 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: 10479798
• Report Number: 2029214-2020-00873
• Device Sequence Number: 2949546
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 09/01/2020

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: 04/29/2021
• Device Model Number: PED-475-30
• Device Catalogue Number: PED-475-30
• Device Lot Number: A637278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR