BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION RX

    MDR report key: 1951125 · Received December 30, 2010

    Report

    Report Number
    MW5018850
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    May 28, 2010
    Report Date
    December 30, 2010
    Manufacturer
    GUIDANT SALES CORPORATION
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, TRANSFERRED FROM OUTLYING FACILITY WITH RECENT NON-STEMI FOR CATH/PCI. A 3.5X15 MULTI-LINK VISION DEPLOYED IN 75% PROXIMAL LAD. DISCHARGED ON ASA AND PLAVIX. HE REPORTEDLY HAD NOT TAKEN PLAVIX SINCE HOSPITALIZATION, AND ON (B)(6) 2010 PRESENTED TO OUTLYING FACILITY WITH STEMI. TRANSFERRED FOR EMERGENT CATH/PCI. FILMS REVEAL TOTALLY OCCLUDED LAD AT SITE OF PREVIOUSLY PLACED STENT WITH THROMBUS. EXPORT THROMBECTOMY PERFORMED. PRE-DILATION WITH 3.5X15 VOYAGER. A 3.5X18 MULTI-LINK VISION DEPLOYED WITH IMMEDIATE POST DILATION WITH COMPLETE STENT EXPANSION. DECISION TO PLACE AN ADDITIONAL STENT AND 3.5X15 MULTI-LINK VISION DEPLOYED. A 3.5X15 QUANTUM MAVERICK TO POST-DILATE THROUGHOUT STENTED AREAS. FINAL FILMS REVEAL GOOD ANGIOGRAPHIC RESULT. PT DISCHARGED ON ASA AND PRASUGREL WITH EXTENSIVE DISCUSSION OF IMPORTANCE OF MEDICAL COMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK VISION RX MAF GUIDANT SALES CORPORATION 9122141

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability