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

Model Number PED-475-35

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline flex pushwire break. That patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of the left ophthalmic artery segment. The aneurysm max diameter was 21mm and the neck diameter was 13mm. Vessel tortuosity was moderate. It was reported that the devices were prepared according to the instructions for use (ifu). During recovery, there was moderate resistance and the pipeline pushwire was broken. The pipeline was released in the marksman microcatheter and could not be pushed out to deploy again. The devices were replaced with another manufacturer's products to complete the procedure. There were no patient symptoms or complications associated with this event.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12526282
• MDR Text Key: 273149362
• Report Number: 2029214-2021-01195
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-475-35
• Device Catalogue Number: PED-475-35
• Device Lot Number: B078298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial