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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR SURPASS EVOLVE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR SURPASS EVOLVE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Migration (4003)
Patient Problem No Information (3190)
Event Date 09/03/2020
Event Type  Malfunction  
Event Description

Surpass evolve device moved after deployment inside the vessel. Serious concern regarding the competence of the technical specialists supporting the case. Lack of knowledge of flow diversion of the technical specialists and proctors supporting the case. Fda safety report id# (b)(4).

 
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Brand NameSURPASS EVOLVE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR
fremont CA 94538
MDR Report Key10507359
MDR Text Key206326706
Report NumberMW5096476
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is this a Reprocessed and Reused Single-Use Device? No

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