BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1679038 · Received May 7, 2010

    Report

    Report Number
    2024168-2010-00922
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    December 26, 2009
    Report Date
    April 13, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    ADVERSE EVENT: SHOCK/ SUB ACUTE STENT THROMBOSIS/DEATH. ONSET OF ADVERSE EVENT: ONE WEEK POST STENT DEPLOYMENT. DEVICE ISSUE. NONE. IT WAS REPORTED THAT IT WAS A VERY CALCIFIED, DIFFICULT CASE. DIFFUSE DISEASE TO BOTH RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. MULTIPLE BALLOONS AND STENTS USED INCLUDING: A NON ABBOTT STENT 3.0 X 32 MM STENT THAT DID NOT CROSS. AFTER MULTIPLE INFLATIONS UP AND DOWN THE RCA, A 2.5 X 12 VISION STENT WAS ATTEMPTED TO CROSS THE RCA AND THE STENT WAS NOTED TO HAVE DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) BALLOON IN THE PROXIMAL TO MID RCA. THE STENT COULD NOT BE DEPLOYED IN A NORMAL FASHION, SO IT WAS COMPRESSED AGAINST THE VESSEL WITH A 3.0 X 28 VISION STENT. THE LESIONS WERE SUCCESSFULLY TREATED WITH THREE ADDITIONAL STENTS (2.5 X 18 MINI VISION IN THE MID LAD, 3.0 X 23 VISION STENT IN THE PROXIMAL LAD, 3.0 X 12 VISION IN THE DISTAL RCA). THE PATIENT WAS DISCHARGED IN STABLE CONDITION. ONE WEEK POST PROCEDURE ON (B) (6) 2009, THE PATIENT WAS READMITTED TO (B) (6) HOSPITAL IN SHOCK AND HAD ST TO BOTH RCA AND LAD ARTERIES AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM MAF ABBOTT VASCULAR CLONMEL NA 9040241

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death