BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 823957 · Received February 28, 2007

    Report

    Report Number
    MW1042066
    Event Type
    Injury
    Date Received
    February 28, 2007
    Date of Event
    November 5, 2006
    Report Date
    February 28, 2007
    Manufacturer
    *
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2006 PT TO OUTLYING ER WITH STEMI. V-FIB ARREST, DEFIBRILLATED X 3, WITH ACLS PROTOCOL. AMIODARONE DRIP AND INTUBATED. TRANSFERRED TO THIS FACILITY FOR EMERGENT CATH/PCI. ON ARRIVAL TO CCL PT AWAKE, RESPONSIVE WITH SPONTANEOUS RESPIRATIONS. EXTUBATED, O2 NOW BY NON-REBREATHER. GIVEN ASA 324 MG PO AND PROCEEDED WITH CATH WHICH REVEALS 100% OCCLUDED PROX LAD. ANGIOMAX DRIP BEGUN. VESSEL DILATED WITH 3.0 X 15 MAVERICK AT 6ATM FOR 30 SECONDS. EXPORT XT THROMBECTOMY CATHETER USED X 2 PASSES. A 3.0 X 24 TAXUS EXPRESS 2 DEPLOYED AT 16 ATM FOR 30 SECONDS. REOPRO DRIP STARTED. RESOLUTION OF THROMBUS WITH BRISK DISTAL FLOW AND 0% RESIDUAL STENOSIS. UNEVENTFUL POST-OP COURSE. DISCHARGED THE NEXT DAY ON ASA, PLAVIX, ALTACE, TOPROL, CRESTOR. FOUR DAYS LATER, PT RE-PRESENTS TO OUTLYING ER WITH STEMI. TRANSFER FOR EMERGENT CATH/PCI. CATH REVEALS 100% OCCLUSION IN PREVIOUSLY PLACED TAXUS STENT IN PROX LAD, SUBACUTE THROMBOSIS. ASA 650 MG PO, EXISTING HEPARIN DRIP. VESSEL DILATED WITH 3.0 X 15 MAVERICK AT 6 ATM FOR 10 SECONDS. EXPORT XT THROMBECTOMY CATHETER USED X 2 PASSES. A 3.5 X 15 QUANTUM MAVERICK AT 12 ATM FOR 30 SECONDS. REOPRO INFUSION BEGUN. RESOLUTION OF THROMBUS WITH BRISK DISTAL FLOW AND 0% RESIDUAL STENOSIS. UNEVENTFUL POST OP COURSE. DISCHARGED 2 DAYS LATER ON ASA, PLAVIX, CRESTOR, DIOVAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP TAXUS EXPRESS 2 MONORAIL MAF * 38970-2430 8634216

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability