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

Model Number PED-475-35

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

The pipeline flex braid implanted in the patient.The broken segment of the pushwire remains in the patient and rest of pushwire was discarded.The device will not be returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that pushwire of pipeline flex broke during the procedure.The patient underwent embolization treatment for a medium unruptured saccular internal carotid artery (ica) aneurysm located in cavernous segment.Measuring 18mmx4mm, landing zone distal 4.9mm proximal 4.8mm.The vessel was observed moderately tortuous.It was reported that due to a narrowing of the cervical carotid, the physician gave nitro.There may have been a small dissection.It was thought of not doing the case.He proceeded.Initially went in with a 4.75x25 pipeline and it was nearly all the way deployed, but we had concern that when trying to run the medtronic catheter through it might pop in and drop it into the aneurysm.Thus, we pulled that out and chose a 4.75 x 35.That was much wagging and receiving and centering, but all in all though pipeline was deploying well as.We were approaching the point of no return marker bands when the catheter curled up like a candy cane.Our fix was to maneuver the medtronic distal access support catheter over the catheter thus straightening out the catheter and deploy the rest of the pipeline in the distal access support catheter.This actually worked well, and the pipeline was now fully deployed with good wall apposition.It was at this point when we try to advance the catheter through the pipeline that we noticed a pipeline wire had separated.The physician took a medtronic revascularization device 6x20 proximal to the deployed pipeline to try to nab the wire from there.Unsuccessful.The physician then tried a 4 x 20 revascularization device to nab from the distal part of the pipeline in the m1.Unsuccessful.Tried a snare retrieval device but unsuccessful.Eventually line for enterprise stance the entire length of the remaining wire to tackle against the vessel wall.Good results.Patient doing fine.There were not any patient symptoms or complications associated with this event.The broken segment left in the patient¿s cavernous ica to m1.The angiographic result post procedure was good.

• 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 ; 9496801345
• MDR Report Key: 10083482
• MDR Text Key: 194754242
• Report Number: 2029214-2020-00480
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016835
• UDI-Public: 00847536016835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: PED-475-35
• Device Lot Number: A861603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 9 YR