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

Model Number PED2-350-20

Device Problems Break (1069); Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2020-0097 for report of other pipeline device. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that two pipeline devices and phenom catheters had movement during placement due to the size of the aneurysm. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery with a max diameter of 35mm and a 14mm neck diameter. It was noted the patient's vessel tortuosity was severe. Dual antiplatelet therapy (dapt) was administered, but the pru level was unknown. It was reported that everything was set up per the instructions for use (ifu), but the size of the aneurysm was too big. When all the devices were in the right position, all of the system fell down, and when the physician tried to recapture the pipeline device, both products got stuck. It was stated this happened with both pipeline and microcatheters attempted to be used to treat the patient. There was no friction or difficulty during delivery or placement, the landing zone was not missed, there was no device jumping, the pipeline was not implanted to cover the aneurysm, and the tip of the catheter moved during deployment. However, it was also stated the bodies of the catheters were entrapped and/or experienced difficult removal with the pipeline devices. The patient did not experience any vasospasm, and there was no medical or surgical intervention required. There was no patient symptoms or complications associated with the event. Ancillary devices include a fargomax + iva80, balt company. Additional information received reported that resistance was in the distal part of the catheter in both cases. The physician had tried to recapture the device and when they felt the pipeline got stuck, they began to recover all of the system for safety and the pipeline released in the catheter. The second device was pulled out with no criteria by the assistant, which is why the pusher was not in the right place. No damage was observed during the procedure, but when they tried to pull back the second device, the assistant pulled too hard and broke the pusher. The procedure was completed by filling the aneurysm with coils.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: 10597982
• MDR Text Key: 208951254
• Report Number: 2029214-2020-00978
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 12/11/2020

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: 02/11/2022
• Device Model Number: PED2-350-20
• Device Catalogue Number: PED2-350-20
• Device Lot Number: A781676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial