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

Model Number PED-400-25

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 03/04/2019

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. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of pipeline flex pushwire break. The patient was undergoing pipeline flex placement in the treatment of a small unruptured saccular right internal carotid artery aneurysm, measuring 7mmx3mm, landing zone distal 3. 9mm, proximal 4. 0mm. The vessel was normal tortuous. The devices were prepared as indicated in the ifu. A continuous flush was maintained during the procedure. It was reported that during the procedure, the pipeline flex became stuck in the microcatheter. The pipeline could not be pushed frmo the microcatheter, leading to stent and ewire cracked. The stent was released in microcatheter and then withdrawn from the patient. The broken segment of the pushwire removed from the patient. There was reportedly no damage to the catheter. There were no 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: 8471341
• MDR Text Key: 140622217
• Report Number: 2029214-2019-00260
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/18/2021
• Device Model Number: PED-400-25
• Device Lot Number: A662945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial