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

Model Number PED-400-14

Device Problems Break (1069); No Apparent Adverse Event (3189)

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

Event Date 09/15/2020

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 pushwire came loose from the device. The patient was undergoing surgery for treatment of a saccular, previously ruptured aneurysm of the right posterior communicating (pcom) artery with a max diameter of 4. 5 mm and a 4 mm neck diameter. It was noted the patient's vessel tortuosity was minimal. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 126. It was reported that the pipeline was advanced through the phenom microcatheter which was distal in the m2 region. The pipeline was then unsheathed in the m1 region and slowly dragged back to the terminus landing zone. During the drag process, the distal end of the pipeline opened. The physician wanted to advance the pipeline distally since they pulled the pipeline down too proximal. The phenom was advanced with a slight pull on the pushwire to recapture the pipeline. Under fluoro, it was noticed the pushwire had no friction and came loose from the device. Since the pipeline had only been deployed about 2-3 mm, the pipeline and microcatheter were removed. There was no vessel injury, and another device 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. Ancillary devices include a 9f terumo pinnacle, ballaste 90cm 6f, 072 navien, headway duo 156cm, phenom 27 150cm, syncro2 soft, target xl 5x10 360.

• 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: 10551747
• MDR Text Key: 207529503
• Report Number: 2029214-2020-00944
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

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: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-400-14
• Device Catalogue Number: PED-400-14
• Device Lot Number: A894611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/22/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial