BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1679024 · Received May 7, 2010

    Report

    Report Number
    2024168-2010-00931
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    April 10, 2010
    Report Date
    April 12, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS AND DEATH ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) AS POTENTIAL ADVERSE EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ADDITIONALLY, IT WAS REPORTED THAT THE VISION STENT WAS IMPLANTED IN AN ACUTE MYOCARDIAL INFARCT (AMI) PATIENT. IT SHOULD BE NOTED THAT TREATING PATIENTS WHO HAVE EXPERIENCED A RECENT (LESS THAN 1 WEEK) ACUTE MYOCARDIAL INFARCTION IS CONTRAINDICATED IN THE IFU. THE 3.5 X 28 XIENCE V (PART 1009542-28, LOT 9102041), INDICATED , IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: POSSIBLE THROMBOSIS/DEATH. ONSET OF ADVERSE EVENT: WITHIN ONE MONTH OF STENT DEPLOYMENT. IT WAS REPORTED THAT APPROXIMATELY EARLY TO (B) (6), A VISION STENT WAS DEPLOYED IN THE CIRCUMFLEX LESION TO TREAT AN ACUTE MYOCARDIAL INFARCT (AMI) PATIENT. THEN ON (B) (6) 2010, A XIENCE V 3.5 X 28 MM STENT WAS DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND DUAL ANTIPLATELET THERAPY (DAPT) WAS PERFORMED (ASPIRIN, PLAVIX, WARFARIN). AFTER DEPLOYMENT OF THE XIENCE V, IVUS WAS PERFORMED AND THE STENT WAS EXPANDED WELL WITH NO ISSUE NOTED. ON (B) (6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CARDIOPULMONARY ARREST (CPAP) AND HE WAS TREATED BY THE PHYSICIAN, BUT LATER DIED. AT THIS POINT, THE PHYSICIAN COMMENTED THAT THERE IS A POSSIBILITY THAT THE THROMBOSIS HAD OCCURRED IN THE VISION OR THE XIENCE STENTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9032541

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| L| R (PART 1009542-28,LOT 9102041)| OTHER: IVUS (ATLANTIS)| DILATATION CATHETER: NC SPRINTER 5.0 15| STENT: 3.5 X 28 MM XIENCE V