BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 2964204 · Received February 15, 2013

    Report

    Report Number
    3005168196-2013-00061
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 18, 2012
    Report Date
    January 16, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS EVENT WAS REPORTED DURING THE PENUMBRA SYSTEM SEPARATOR 3D CLINICAL TRIAL. THE INFORMATION AVAILABLE IS LIMITED TO PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL AND INFORMATION FROM THE CLINICAL TRIAL RESEARCH COORDINATORS. FURTHER CLARIFICATION HAS BEEN REQUESTED OF THE HOSPITAL AS TO THE DEVICE RELATIONSHIP TO THE EVENT HOWEVER, THE HOSPITAL HAS NOT PROVIDED ANY FURTHER DETAIL. THEREFORE, THIS MDR IS BEING SUBMITTED BECAUSE THE DEVICE RELATIONSHIP TO THE EVENT IS STILL CONSIDERED "UNCERTAIN". ANY ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL AS IT RELATES TO THIS EVENT WILL BE SUBMITTED IN A FOLLOW-UP MDR. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR TREATMENT OF ACUTE STROKE IN HER LEFT MCA ON (B)(6) 2012 AND ENROLLED IN THE SEPARATOR 3D TRIAL AS A ROLL IN PATIENT, WITH TREATMENT BY THE SEPARATOR 3D DEVICE. THE THROMBUS WAS INITIALLY ACCESSED WITH THE PENUMBRA 5MAX COAXIALLY OVER THE VELOCITY CATHETER. THE PATIENT WAS ADMINISTERED 2.5 MG OF IA NICARDIPINE AND THE SEPARATOR 3D DEVICE WAS DEPLOYED WITH ONE ATTEMPT AT CLOT REMOVAL UNDER 5MAX CATHETER ASPIRATION. THE VESSEL WAS SUCCESSFULLY REVASCULARIZED WITH NO PROCEDURAL COMPLICATIONS. THE DAY AFTER THE PROCEDURE, THE PATIENT SUFFERED FROM THREE EVENTS WITH REPORTED "UNCERTAIN" RELATIONSHIP TO THE PENUMBRA SYSTEM: VASOSPASM OF THE LEFT CERVICAL ICA, VASOSPASM IN BRANCHES OF LEFT ECA AND HYPERMIA OF LEFT NASOPHARYNX FROM LEFT ECA. ALL EVENTS WERE NOT SERIOUS AND RESOLVED THE SAME DAY ((B)(6) 2012) WITH REMEDIAL THERAPY GIVEN FOR THE VASOSPASMS. ON (B)(6) 2013, THESE EVENTS WERE REPORTED TO PENUMBRA FOR THE FIRST TIME IN THE EDC AS HAVING "UNCERTAIN" RELATIONSHIP TO THE STUDY DEVICE. THIS WAS FOLLOWED UP WITH EMAILS FOR CONFIRMATION TO THE STUDY TEAM AT THE SITE, BUT NOTHING HAS BEEN CLARIFIED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00062.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69007 VELOCITY DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F28156

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention