BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI LINK VISION RX

    MDR report key: 3231316 · Received July 11, 2013

    Report

    Report Number
    MW5030899
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2012 ADMITTED THROUGH ED WITH USA. TO CCL (B)(6) 2012, FILMS REVEAL 99% DISTAL RCA WITH LARGE THROMBUS. PREDILATED WITH 2.5X15 NC TREK OTW, AND 3.5X18 MULTI VISION RX DEPLOYED WITH GOOD RESULTS. DISCHARGED ON MEDICINES INCLUDING ASA, PLAVIX X 1 MONTH, AND COUMADIN. ON (B)(6) 2013, PT WAS AT AN OUTPATIENT SURGERY CENTER FOR SHOULDER SURGERY. POST OP IN RECOVERY, SUFFERED A STEMI WITH VFIB ARREST. COUMADIN HAD BEEN HELD 7 DAYS PRIOR TO SURGERY, UNABLE TO DETERMINE IF ASA HAD BEEN STOPPED AS WELL. BROUGHT EMERGENTLY TO CCL, FILMS REVEAL 100% THROMBOTIC OCCLUSION OF STENT IN DISTAL RCA. THROMBECTOMY WITH SEVERAL PASSES WITH IMPROVED APPEARANCE. DILATED WITH 4.0X15 NC TREK. GIVEN THE PT'S MULTIPLE COMORBIDITIES, AND NEED FOR COUMADIN, AS WELL AS METASTATIC CA, IT WAS FELT ANGIOPLASTY ALONE WOULD BE BEST TREATMENT. GOOD ANGIOGRAPHIC RESULT WITH 10% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321257 MULTI LINK VISION RX MULTI LINK VISION RX MAF ABBOTT VASCULAR DEVICES 2032841

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention