BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 961778 · Received November 20, 2007

    Report

    Report Number
    2024168-2007-00500
    Event Type
    Injury
    Date Received
    November 20, 2007
    Date of Event
    June 27, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: SUBACUTE THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A MAUDE REPORT, THAT THE PT WAS TRANSFERRED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION ONSET THREE DAYS PRIOR. A CORONARY ANGIOGRAPHY IN 07 REVEALED 100% OCCLUSION OF THE MID LEFT ANTERIOR DESCENDING. THE STENOSIS WAS DILATED WITH A 2.5 X 20 BALLOON CATHETER AND A 2.25 X 28 MULTILINK MINI VISION STENT WAS IMPLANTED. MEDICATIONS THAT WERE ADMINISTERED INCLUDED ANGIOMAX BOLUS AND INFUSION, PLAVIX, AND ASA. IN 2007, AN 0826 EKG REVEALED ST ELEVATION AND THE PT COMPLAINED OF CHEST PAIN OF TEN ON A ONE TO TEN SCALE. WHEN THE PT WAS BROUGHT BACK TO THE CATH LAB 100% SUBACUTE THROMBOSIS WAS FOUND IN THE PROXIMAL EDGE OF THE STENT. THE LESION WAS DILATED WITH A 2.5 X 15 BALLOON CATHETER AND ANOTHER CO'S STENT WAS IMPLANTED. MEDICATIONS ADMINISTERED TO THE PT DURING THE PROCEDURE INCLUDED HEPARIN, REOPRO, CONTINUED ASA, AND PLAVIX. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7041031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R