BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2230728 · Received August 17, 2011

    Report

    Report Number
    3005168196-2011-00301
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A POTENTIAL ADVERSE EVENT ASSOCIATED WITH PENUMBRA COIL 400 IS VESSEL PERFORATION AND IS INCLUDED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. IT WAS NOTED THAT THERE WAS SOME CALCIFICATION OF THE PATIENT'S ANEURYSM AND THAT THIS, IN COMBINATION WITH THE SPEED WITH WHICH THE COIL WAS DEPLOYED AND THE LIMITED VIEW USED DURING COIL ADVANCEMENT, LIKELY CONTRIBUTED TO THE ANEURYSM RUPTURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION (IMPLANTED IN PATIENT). THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE UNRUPTURED ANEURYSM, MEASURING 10.8 X 8.4MM, WAS REACHED USING THE PENUMBRA PX400 MICROCATHETER AND A GUIDEWIRE. AN 11X45 PENUMBRA COIL 400 WAS DEPLOYED AND DETACHED SUCCESSFULLY. A 6X15 WAS THEN DEPLOYED VERY QUICKLY USING AN UNSUBTRACTED AP VIEW ONLY. IT APPEARED TO HAVE GONE IN VERY WELL UNTIL THE LATERAL ROADMAP VIEW WAS USED AND IT WAS CLEAR THAT THE COIL HAD RUPTURED THE BACK OF THE ANEURYSM, CAUSING A FEW LOOPS TO ESCAPE. THE COIL WAS QUICKLY DETACHED AND 5X13 AND 5X9 PENUMBRA COILS WERE QUICKLY USED TO TRY TO STEM ANY BLOOD LOSS. THESE TWO COILS WERE SUBSEQUENTLY REMOVED. THE BLEEDING APPEARED TO BE UNDER CONTROL AND EXTRA COILS WERE ADDED (BOSTON). AT THE END OF THE PROCEDURE, THE ANEURYSM APPEARED TO BE ANGIOGRAPHICALLY WELL FILLED AND THE PHYSICIAN WAS FAIRLY HAPPY THAT THE PATIENT WAS OK. IT WAS NOTED THAT THERE WAS SOME CALCIFICATION OF THE PATIENT'S ANEURYSM. DURING A FOLLOW UP IT WAS ALSO NOTED THAT THE PATIENT WAS DOING WELL AND WAS RELEASED FROM THE HOSPITAL AFTER ONLY A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F18705

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention