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

Model Number PED-500-30

Device Problem Activation Failure (3270)

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

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event 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
• 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: 10536680
• MDR Text Key: 207049124
• Report Number: 2029214-2020-00930
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019782
• UDI-Public: 00847536019782
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Date Device Manufactured: 03/16/2020
• 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