MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-25

Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012)

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

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the physician tried delivering the first pipeline device into the siphon area but the patient's tortuous anatomy caused a lot of resistance, resulting in the pipeline becoming jammed inside the microcatheter in the distal end during delivery.As a result the physician changed the whole system, thinking the xt27 could have a better result.However, the issue occurred again with the pipeline becoming stuck due to high resistance from the patient's vessel tortuosity.The system was then changed once again with the pipeline able to be delivered successfully using an xt27, with it noted that although there was resistance, they could manage it better.There was also movement during placement of the tip of the catheter with the pipeline also jumping during deployment.The pipeline was placed at least 3 mm past the aneurysm neck on either side, and no side branches were covered.The patient was undergoing treatment of an unruptured, saccular aneurysm in the left ica with a max diameter of 8mm and a neck diameter of 9mm.Dual antiplatelet treatment was administered.The patient's vessel tortuosity was severe.During the case the physician attempted to release slack from the system but it did not resolve the issue.Catheter accordion damage was noted in the distal section with the pushwire also kinked.The devices were flushed/prepared as indicated per the ifu.The pipeline was resheathed less than or equal to 2 times.Ancillary devices include a neuron max sheath, neruon delivery 070 guide catheter, marksman microcatheter, transend guidewire.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7991170
• MDR Text Key: 124560332
• Report Number: 2029214-2018-00866
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: VM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: A262807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Date Device Manufactured: 04/17/2016
• 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