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

Model Number PED-425-35

Device Problems Unintended Ejection (1234); Physical Resistance/Sticking (4012)

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

Event Date 02/25/2019

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 the suspect medical device section.Brand name: pipeline flex with shield technology model number: ped2-425-35.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that first marksman catheter become damaged and during removal of the pipeline it was locked inside the marksman catheter.Second pipeline device opens prematurely.The patient was undergoing embolization treatment for a medium size unruptured saccular left internal carotid artery aneurysm, measuring 15mmx20mm.Landing zone distal 3.5, proximal 4.2mm.The vessel was severely tortuous.The pipeline and any accessory devices were prepared as indicated in the ifu.It was reported that during the procedure, a pipeline device was deployed.The device opened but did not open properly, for this reason the physician tried to recover the pipeline but the device did not advance again and released inside the microcatheter.The pipeline that released within the microcatheter was withdrawn.The procedure was completed using a new device.There were not any patient symptoms or complications associated with this event.

• 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: 8481197
• MDR Text Key: 141204700
• Report Number: 2029214-2019-00284
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2020
• Device Model Number: PED-425-35
• Device Lot Number: A452078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Date Device Manufactured: 04/28/2017
• 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: 60 YR
• Patient Weight: 70