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

Model Number PED-450-18

Device Problem Break (1069)

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

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the distal tip lead wire detached during recapture. The detached wire was recaptured with the phenom plus and was successfully removed. Resistance was felt on retrieval. The patient injury occurred. The post angiographic results were good. The devices were prepared and use per the instructions for use (ifu). The patient underwent treatment of a left internal carotid artery (ica), unruptured, saccular aneurysm. The distal landing zone was 3. 7 mm and the proximal was 4. 1 mm. The vessel anatomy was severe in tortuosity.

• 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: 9665018
• MDR Text Key: 195548302
• Report Number: 2029214-2020-00097
• 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: 04/24/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-450-18
• Device Lot Number: A924638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial