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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 PED3-027-400-30
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a pipeline vantage has twisted and failed to open proximal. The patient was being treated for an unruptured saccular aneurysm. On the left side internal carotid artery.   during the deployment of the stent, it has twisted, and couldn't be opened anymore. The devices were prepared as indicated in the instructions for use. More than 50% had been deployed when it failed to open. The pipeline was resheathed more than 2 times. Patient is in good condition, the twisted device has been removed and an other pipeline has been implanted which has worked properly. Dual antiplatelet treatment was administered.   no symptoms were reported.   ancillary devices: phenom microcatheter.
 
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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 Key12455628
MDR Text Key280598969
Report Number2029214-2021-01154
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeHU
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 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-400-30
Device Catalogue NumberPED3-027-400-30
Device Lot NumberB211371
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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