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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL 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 Key7724938
MDR Text Key115189727
Report Number2029214-2018-00669
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PED-400-20
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2020
Device Model NumberPED-400-20
Device Lot NumberA508397
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2018 Patient Sequence Number: 1
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