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

Model Number PED-450-25

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

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 while unsheathing the pipeline, the middle section could not be opened successfully. It was suspected the pipeline had been twisted, which caused for the difficulty of deployment. It was noted the stent was positioned in a bend, more than 50% had been deployed, resheathing was performed more than twice, and no additional steps were taken in an attempt to open the pipeline. A replacement pipeline was used to complete the procedure with no issues. 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 angiography showed the stent covered the aneurysm and attached to the wall perfectly. The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the internal carotid artery c4 with a max dia meter of 14 mm and a 6 mm neck diameter. It was noted the patient's vessel tortuosity was severe. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown. Ancillary devices include a neuron 088 80cm, navien 058 115cm, marksman 150cm.

• 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: 10734458
• MDR Text Key: 213048672
• Report Number: 2029214-2020-01056
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P100018.S011
• 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: 12/22/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/05/2022
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: A859773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial