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

Model Number PED-400-20

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the pipeline flex device' pushwire broke. The patient underwent embolization treatment for a unruptured amorphous supraclinoid internal carotid artery (ica), measuring 6mmx4mm, landing zone distal 3. 5mm proximal 3. 7mm. The vessel was observed normal tortuous. It was reported that catheter was flushed and prepared as per instructions for use (ifu). It was delivered to the desired location without any trouble. Ped-400-20 (ped) was advanced into the microcatheter. It was pushed well without any resistance, it was then attempted to be deploying but the operator was not happy with the opening hence tried to resheathed it with the microcatheter. Resistance was felt and all of a sudden pipeline pusher wire was moving freely into the catheter. The complete system was taken out to inspect. It was found that the distal portion of ped was broken and the catheter distal part was stretched. No patient symptoms or complications were associated with this event. Dual antiplatelet treatment was administered. Pru level was 157. The catheter was flushed as indicated per the ifu. The post procedure angiography results show successful deployment of another ped.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9450654
• MDR Text Key: 194321907
• Report Number: 2029214-2019-01217
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/16/2021
• Device Model Number: PED-400-20
• Device Catalogue Number: PED-400-20
• Device Lot Number: A725130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial