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

Model Number PED-400-20

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009); Activation Failure (3270); Migration (4003)

Patient Problems Therapeutic Response, Decreased (2271); Foreign Body In Patient (2687); No Information (3190)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

The pipeline was not returned as it remains implanted in the patient.For pipeline: please refer to mdr# 2029214-2018-00668.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the treatment of a cerebral aneurysm located in the right cavernous carotid artery, the medtronic flow diverter was noted to have failed to open completely and a cavernous carotid fistula (ccf) was observed on angiography after the pipeline was opened.The medtronic microcatheter was then delivered but could not cross through the medtronic flow diverter.In doing so, the pusher migrated to the vessel proximal to the neck of aneurysm.In an attempt to reposition the pushwire, it was found to only advance toward the ccf which caused an expansion of the fistula.It was then determined that to open the proximal section of the pipeline, the sl10 microcatheter would be used to deliver the hyperform through the anterior communicating artery for percutaneous transluminal angioplasty (pta).However, during this process, the distal section of the medtronic flow diverter had migrated into the aneurysm.Intervention by means of open surgery was performed in order to bypass the sta and mca.Post procedure it was noted that the medtronic support catheter 6fr was used instead of the usual 5fr, which is believed to be the reason for the difficulty in maneuvering when attempting to reposition the pushwire and lead to the expansion of the fistula.Adverse effects had occurred during the procedure and intervention was required to complete the procedure.It was noted that the vessel had a medium diameter and was severely tortuous.It was unknown if there was any difficulty / resistance while delivering the medtronic microcatheter and medtronic distal support catheter.The device will not be returned as it was discarded.The outcome of the procedure and the patient¿s current condition was not disclosed.There was no mention of vessel sacrifice.

Manufacturer Narrative

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

• 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: 7724938
• MDR Text Key: 115189727
• Report Number: 2029214-2018-00669
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PED-400-20
• 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,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: PED-400-20
• Device Lot Number: A508397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 08/15/2017
• 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 Outcome(s): Required Intervention; Disability
• Patient Age: 68 YR