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

Model Number	PED-500-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2020
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
Medtronic received a report that two pipelines failed to open.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the right internal carotid artery.It was noted the patient's vessel tortuosity was moderate.It was reported that the distal segment of the pipeline (pli-10) failed to open.The pipeline was removed from the patient, and a second pipeline (pli-20) was used.The second pipeline failed to open in the middle section.The devices were not positioned in a bend, less than 50% had been deployed, it was unknown how many resheathing attempts were performed, and no additional steps were done to open the devices.The second pipeline was removed from the patient, and the third and fourth pipeline were deployed successfully.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.Post-procedure angiographic results showed the aneurysm was covered.Ancillary devices include a neuronmax, phenom plus, phenom27.

• 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: 10536680
• Report Number: 2029214-2020-00930
• Device Sequence Number: 3934362
• Product Code: OUT
• UDI-Device Identifier: 00847536019782
• UDI-Public: 00847536019782
• 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): 09/15/2020

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: 03/16/2023
• Device Model Number: PED-500-30
• Device Catalogue Number: PED-500-30
• Device Lot Number: A993680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1