BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1824469 · Received August 30, 2010

    Report

    Report Number
    2024168-2010-01790
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE VISION INSTRUCTIONS FOR USE. 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 OR DESIGN. THE 3.5 X 18 MM MULTI LINK VISION (PART 1007849-18, LOT 0040241), IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ACUTE STENT THROMBOSIS REQUIRING MEDICAL INTERVENTION. ONSET OF ADVERSE EVENT: WITHIN 24 HOURS OF THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CARDIAC CATH LAB WITH AN ACUTE MYOCARDIAL INFARCTION (AMI). THE PATIENT WAS TREATED WITH TWO VISION STENTS IN THE CIRCUMFLEX. WITHIN 24 HOURS THE PATIENT EXPERIENCED ACUTE STENT THROMBOSIS OF BOTH VISION STENTS. THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB AND WAS TREATED WITH AN NC VOYAGER AND AN ASPIRATION CATHETER TO REMOVE THE STENT THROMBOSIS. THE PATIENT WAS PUT ON INTRA AORTIC BALLOON PUMP (IABP) AND REMAINED IN THE HOSPITAL IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0060341

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R STENT:3.5 X 18 MM MULTI LINK VISION(PART1007849-18| LOT 0040241)