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

Model Number PED-450-20

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the  the patient was undergoing treatment for an unruptured, fusiform complex aneurysm located in the ophthalmic artery segment. The max diameter was 9mm, and the neck diameter was 7mm. The patient's vessel tortuosity was normal. The landing zone was 3. 9mm distal, and 4mm proximal. The access vessel was the femoral artery, which was 6mm in diameter. It was reported that the pipeline was slowly delivered through the y valve, the protective sheath was removed, and the doctor continued to push with great resistance. When the pipeline tip was deployed, it was difficult to open the middle section. After the successful deployment, the rivet adhered to the wall well. They pushed the marksman up and recovered the pipeline guidewire. The recovery was difficult. Repeated adjustments were unsuccessful and the forward push recovery was unsuccessful. The navien also failed to pass the proximal end of the pipeline. The push guide wire could only be withdrawn without being recovered into marksman. In this process, the protective sleeve of the tip of the push guide wire was hooked with the deployed pipeline, and then the stent was also hooked when it was moved forward and then withdrew. There was readjustment and withdrawal, causing the pipeline to fall off into the aneurysm. Observing the marksman catheter in vitro, the soft section at the tip end was accordion-like, and the pipeline protective sleeve at the tip end was stuck at the tip end of the catheter, but the recovery in vitro was still unsuccessful. A new catheter was used and deployed the stent, but they still couldn¿t recover the pipeline push guide wire into the marksman. After adjustment, the catheter and pipeline guide wire were slowly withdrawn as a whole, and then hooked to the pipeline so that the device was retracted for a certain distance and almost fell off again.  the pipeline tip-end protective sleeve could not be resheathed into the marksman, and the material was very hard, so it still could not be resheathed in vitro after withdrawing the stent. The devices were replaced, and the patient did not experience any injury or complications. Angiographic results post procedure showed retention in the aneurysm. The devices were prepared and flushed according to the instructions for use (ifu).

Manufacturer Narrative

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

• 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: 12759805
• MDR Text Key: 285227003
• Report Number: 2029214-2021-01408
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: B250922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial