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

Model Number PED-450-18

Device Problems Positioning Failure (1158); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 03/12/2019

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 section d.Brand name: pipeline flex with shield technology model number: ped2-450-18.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that there was excessive friction felt all the way up to the mca vessel, and upon opening the device "did not flare" correctly and slipped from the optimum position.As a result the catheter and wire position were adjusted, causing the device position to be lost.The system was then removed.The patient was undergoing surgery for treatment of an unruptured, saccular ica cavernous aneurysm with a max diameter of 20mm and a neck diameter of 10mm.It was noted that the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered with a pru level of 319 shown, and the physician also gave an iv of tirofiban during the procedure.Angiographic result post procedure showed that the aneurysm neck was occluded.The devices were prepared as indicated per the ifu.

• 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 ; 7635263305
• MDR Report Key: 8485652
• MDR Text Key: 141203323
• Report Number: 2029214-2019-00306
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2019
• Device Model Number: PED-450-18
• Device Lot Number: A292781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR