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

Model Number PED-375-12

Device Problem Break (1069)

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

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received; however, the analysis has not been completed. The cause of the reported event has not been determined at this time. Once the analysis has been completed, a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the distal tip of the delivery wire of the medtronic flow diverter separated, and detached at the solder joint post successful deployment. The devices were prepared and use per the instructions for use (ifu). The angiographic result post the procedure showed the ped-375-20 correctly and successfully placed over medium sized wide-necked aneurysm in the left internal carotid artery at the terminus segment. The patient was doing well post procedure. The medtronic catheter and delivery wire with detached tip of the flow diverter device will be returned for analysis. The patient underwent treatment of a left internal carotid artery (ica), at the level of the terminus segment of the ica, unruptured, saccular aneurysm. The max diameter was 4 mm x 4 mm and the neck was 3 mm. The distal landing zone was 4 mm and the proximal was 5 mm. The vessel anatomy was minimal in tortuosity.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: 9729111
• MDR Text Key: 198537550
• Report Number: 2029214-2020-00154
• 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: 03/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-375-12
• Device Lot Number: A848725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial