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

Model Number PED-475-10

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10698183
• MDR Text Key: 213049308
• Report Number: 2029214-2020-01033
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016590
• UDI-Public: 00847536016590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/19/2020
• Date Device Manufactured: 04/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR