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

Model Number PED-500-12

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while attempting to open the device, it would not open correctly in the distal section of the pipeline.It was stated it looked like a tulip.More than 50% of the pipeline had been deployed when it failed.It was resheathed less than or equal to 2 times.The pipeline was positioned in a distal part of a bend.No additional steps or other devices were required to open the pipeline.The pipeline was resheathed and removed with the microcatheter from the patient.Angiographic result post procedure was good.The patient was undergoing surgery to treat an unruptured, saccular aneurysm located at the opthalmic artery with a max diameter of 5mm and a neck diameter of 4mm.It was noted the vessel tortuosity was severe.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.

• 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: 10993291
• MDR Text Key: 220978368
• Report Number: 2029214-2020-01285
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016897
• UDI-Public: 00847536016897
• 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: 12/11/2020

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: 08/19/2021
• Device Model Number: PED-500-12
• Device Catalogue Number: PED-500-12
• Device Lot Number: A694934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/11/2020
• Date Device Manufactured: 08/20/2018
• 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: 30 YR