MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT

Model Number PED2-500-20

Device Problem Activation Failure (3270)

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

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the first pipeline (4. 5 mm x 30 mm) experienced catheter kickback during deployment, and the device became stuck in the xt27 microcatheter. It was noted there was no friction during delivery, and the catheter tip was under stress due to the proximal curves which resulted in the tip moving and the kickback. The physician removed the catheter and pipeline, and a new pipeline (4. 75 mm x 20 mm) was used with a phenom 27 microcatheter. The pipeline was delivered and opened in the desired landing zone. However, the distal segment of the pipeline failed to open despite more than two resheathing attempts. The pipeline was not positioned in a bend, and upon opening more of the device, it was noticed the body of the pipeline opened normally. The pipeline and phenom microcatheter were removed from the patient. A third pipeline (5 mm x 20 mm) experienced the same event as the second pipeline: the dista l end failed to open. After resheathing multiple times without success, the physician removed this pipeline as well. A competitor's product was then used to complete the procedure with no reported 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. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left c6 internal carotid artery with a max diameter of 30 mm and a >10 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Refer to manufacturer report 2029214-2020-00983 for details pertaining to the related reportable event.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• 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: 10604108
• MDR Text Key: 209385946
• Report Number: 2029214-2020-00984
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/25/2022
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: A772800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• 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?: Yes
• Date Device Manufactured: 01/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial