BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 679134 · Received February 23, 2006

    Report

    Report Number
    2024168-2006-00082
    Event Type
    Injury
    Date Received
    February 23, 2006
    Date of Event
    October 24, 2005
    Report Date
    October 24, 2005
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    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

    SOMETIME AFTER THE STENT PROCEDURE THE PATIENT EXPERIENCED SUB ACUTE THROMBOSIS (SAT). THERE WAS NO INFORMATION AVAILABLE REGARDING WHAT DEVICE CAUSED THE SAT OR IF THERE WAS TREATMENT OF THE SAT. IN THE ABSENCE OF THIS INFORMATION THIS WILL BE FILED BASED ON THE ASSUMPTION THAT THE STENT CAUSED OR CONTRIBUTED TO THE SAT AND THAT MEDICAL INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention