BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 693558 · Received March 27, 2006

    Report

    Report Number
    2024168-2006-00217
    Event Type
    Injury
    Date Received
    March 27, 2006
    Report Date
    February 25, 2006
    Manufacturer
    GUIDANT CORPORATION, ADVANCED CARDIOVASCULAR SYSTE
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2006, TWO VISION STENTS WERE IMPLANTED ADJACENTLY IN THE MID RCA. AFTER IMPLANTATION, SUBACUTE THROMBOSIS (SAT) OCCURRED IN FEBRUARY (THE EXACT DATE IS UNKNOWN). THE PATIENT WAS REPORTED TO HAVE POOR BLOOD FLOW. A LONG STENT STRUT, TWO OF 3.5MM LONG, STENT WAS IMPLANTED ADJACENTLY, WHICH WOULD HAVE INCREASED THE RISK OF SAT. INTERVENTION WAS REQUIRED TO TREAT THE SAT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT CORPORATION, ADVANCED CARDIOVASCULAR SYSTE NA 5082431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention