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

Model Number PED2-450-20

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 09/29/2020

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 the pipeline could not be delivered through the marksman, and the distal segment failed to open. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right posterior communicating (pcom) artery with a max diameter of 4 mm and a 3 mm neck diameter. It was noted the patient's vesseltortuosity was severe. Dual antiplatelet therapy (dapt) was administered: prasugrel. It was reported that the marksman microcatheter was positioned in sector m1/m2, and an attempt was made to deploy the pipeline. However, force was exerted, but it was not possible to advance the pipeline. The stent did not come out of the marksman, and the entire set was removed. It was also stated the distal segment of the pipeline failed to open. The stent was not positioned in a bend, less than 50% was deployed, and resheathing was performed less than three times. A replacement pipeline was used to complete the procedure. 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 satisfactory results. Ancillary devices include a cook 8fr, marksman, avigo guidewire.

• 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: 10661585
• MDR Text Key: 213045976
• Report Number: 2029214-2020-01015
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 12/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: A996944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial