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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-027-600-50
Device Problems Positioning Failure (1158); Unintended Ejection (1234); Activation, Positioning or SeparationProblem (2906); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
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 giant aneurysm had been previously treated with a pipeline device, coils, and a solitaire ab (sab) device. Navigation distal to the intended landing zone was difficult as it was passing through two existing stents. The process involved multiple catheter exchanges and a balloon. Approximately two hours had elapsed. The phenom was tracked beyond the intended landing zone distal to the markers of the sab stent. The location was distal to the ophthalmic artery origin. The vantage device was opened in the ophthalmic artery segment  (c6) and dragged back into the existing sab. The stent landed in the c5/distal c4 segment. Proper wall apposition around the cavernous bend was not achieved. The physician continued to deploy the device, and it expanded with some manipulation until reaching the proximal marker of the sab. The proximal end of the sab was at the proximal c3 and distal c 2 segments, the vantage looked like an hourglass shape: opened distal and proximal to this location. The physician attempted to recapture the vantage device, however, the microcatheter jumped forward and the stent inverted into itself. The tip coil had come back significantly and detachment occurred. Attempts to pass through the inverted stent segment was unsuccessful. The physician proceeded to balloon the segment several times. Post angioplasty, there was still no access beyond this point, and the procedure was terminated. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery (ica) with a max diameter of >20 mm and a >10 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered, the platelet reactivity units (pru) level was unknown. It was reported the pipeline was used for an off-label indication: aneurysm previously treated with a pipeline and solitaire ab placed inside of it. Ancillary devices include a neuron max 088 80cm, neuron max 088 90cm, navien 072 first,  navien 058 115cm, phenom 027, asahi wire 300cm, traxcess 14 wire, scepter balloon.
 
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Brand NamePIPELINE VANTAGE WITH SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12223301
MDR Text Key263389408
Report Number2029214-2021-00919
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-600-50
Device Catalogue NumberPED3-027-600-50
Device Lot NumberB188961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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