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

Model Number PED2-350-30

Device Problem Break (1069)

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

Event Date 08/05/2019

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 receive report that after the uneventful navigation and deployment of the pipeline flex, when an attempt was made to raise microcatheter to collect the sleeve. The delivery pusher was unable to be pulled in the middle. The delivery pusher was pulled, and movement of the wire could not be found, so it was judged that the wire had broken. However, the delivery pusher was almost retracted in microcatheter, and the delivery pusher was pulled out together with marksman. The delivery pusher was removed from microcatheter outside the body, and the breakage was confirmed visually. The break was in the proximal section of the pushwire. There was no resistance felt during the use of the devices. This event occurred during the treatment of an ica-cs that was not ruptured. The max diameter was about 15mm with a neck width of 5mm. The distal landing zone was 3. 4mm and the proximal was 4. 5mm. The anatomy was moderate in tortuosity. There was no patient injury. There are no images. The devices were prepared and used per the instructions for use (ifu).

• Brand Name: PIPELINE FLEX WITH SHIELD
• 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 ; 7635263305
• MDR Report Key: 8893315
• MDR Text Key: 154412799
• Report Number: 2029214-2019-00842
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• 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: 10/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-350-30
• Device Lot Number: A821016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial