BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION OTW

    MDR report key: 1951124 · Received December 30, 2010

    Report

    Report Number
    MW5018849
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    August 6, 2010
    Report Date
    December 30, 2010
    Manufacturer
    GUIDANT SALES CORP
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, TRANSFERRED HERE FROM THE FIELD BY HELICOPTER FOR STEMI. FILMS REVEAL 99% MID RCA LESION AT THE LEVEL OF ACUTE MARGINAL, FELT TO BE THE CULPRIT VESSEL. TWO 3.0X28 MULTI-LINK VISION STENTS DEPLOYED. DISCHARGED ON ASA AND PLAVIX. ON (B)(6) 2010 AGAIN TRANSFERRED FROM THE FIELD BY HELICOPTER FOR STEMI. PT REPORTS RECENTLY COMING OFF PLAVIX ALTHOUGH CANNOT GIVE EXACT DATE. EMERGENTLY TO CCL, FILMS REVEAL 100% OCCLUSION WITH THROMBUS OF PREVIOUSLY PLACED STENTS. PLAN IS FOR ATTEMPTED PCI. A 2.5X20 APEX TO DILATE. SOME REPERFUSION WITH INFLATIONS, BUT HEART RATE DECREASED TO 40'S, AND ARTERIAL PRESSURE TO 30'S, NON-INVASIVE BP 60-70'S. DOPAMINE, TEMPORARY PACER, AND MORE INFLATIONS PERFORMED. HYPERTENSION CONTINUES. IABP INSERTED AND THEN FURTHER FILES TAKEN THAT REVEAL RESTENOSIS. WITH CARDIOGENIC SHOCK AND KNOWN DISEASE IN LAD AND CIRC, EMERGENT CAB FELT TO BE BEST CHANGE AT COMPLETE REVASCULARIZATION. CAB PERFORMED (B)(6) 2010, DISCHARGED TO EXTENDED HEALTHCARE FACILITY (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK VISION OTW MAF GUIDANT SALES CORP 9010741

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability