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

Model Number	PED-475-10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2020
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 that a ped-425-12 and a ped-450-10 were implanted into the cavernous segment of the internal carotid artery (ica) with no issues.A third pipeline was then selected (ped-475-10), prepared per the instructions for use (ifu), and delivered to the aneurysm site.It was noticed the distal segment of the pipeline failed to open upon unsheathing from the phenom 27 catheter.The pipeline was not positioned in a bend, less than 50% was opened, resheathing was performed less than three times, and no additional steps were taken in an attempt to open the pipeline.The doctor removed the pipeline from the patient.There was no injury to the patient, and post-procedure angiography showed the aneurysm neck was covered with the two implanted pipelines.The patient was undergoing surgery for treatment of a saccular, thrombosed aneurysm of the right cavernous segment of the ica with a max diameter of 6 mm and a 3 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was within acceptable levels.

• 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: 10698183
• Report Number: 2029214-2020-01033
• Device Sequence Number: 3708839
• Product Code: OUT
• UDI-Device Identifier: 00847536016590
• UDI-Public: 00847536016590
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/19/2020

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: 04/18/2022
• Device Model Number: PED-475-10
• Device Catalogue Number: PED-475-10
• Device Lot Number: A817769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR