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

Model Number PED-400-20

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. The device involved in this event is not approved in the us; the device's brand name and model number are provided below. This report is being filed against a similar device, which is provided in brand name: pipeline flex with shield technology model number: ped2-400-20. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline was deployed with no concerns. The tip coil was retrieved with the microcatheter per the ifu into the distal access catheter, and the microcatheter removed for final dsa run during which something was noted to travel forward. Imaging showed the tip coil sitting at the base of the cavernous carotid segment, which was subsequently received with a stent. A second photo showed what appears to be the wire snapped off just proximal to the resheathing pad. There were no further complications. Post procedure angiographic results were good. The vessel was normal tortuous.

• Brand Name: PIPELINE FLEX WITH SHIELD TECHNOLOGY
• 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: 8810181
• MDR Text Key: 151713259
• Report Number: 2029214-2019-00767
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/21/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/25/2022
• Device Model Number: PED-400-20
• Device Lot Number: A772796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial