BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 799629 · Received December 21, 2006

    Report

    Report Number
    6000093-2006-02677
    Event Type
    Injury
    Date Received
    December 21, 2006
    Date of Event
    November 27, 2006
    Report Date
    December 4, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6. THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 6043522 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE ET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, POST STENT DEPLOYMENT, THE PATIENT EXPERIENCED CARDIAC ARREST. THE INDEX PROCEDURE TREATED A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS 3.5 MM WIDE, 20 MM LONG, AND 95% STENOSED. THERE WAS NO CALCIFICATION NOR TORTOUSITY. THE PHYSICIAN PREDILATED THE LESION PROR TO PLACING A 3.5 X 24 MM EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT RECEIVED BIVALIRUDIN AND EPTIFIBATIDE DURING THE PROCEDURE. 15 MINUTES AFTER STENT DEPLOYMENT, THE PATIENT HAD NO REFLOW AND SUBSEQUENT EPISODES OF VENTRICULAR FIBRILLATION WHICH LED TO FULL CARDIAC ARREST. THE PATIENT WAS TREATED WITH EXTERNAL CARDIAC DEFIBRILLATION, CHEST COMPRESSIONS, EPINEPHRINE, EVENTUAL VENTILATION AND INTRA AORTIC BALLOON PUMP (IABP) PLACEMENT. THE IABP WAS REMOVED THE NEXT DAY. THE PATIENT HAD A RESULTING HEMATOMA WHICH RESOLVED. THE PATIENT WAS EXTUBATED 2 DAYS LATER. DUE TO FURTHER EPISODES OF VENTRICULAR TACHYCARDIA, AN IMPLANTABLE DEFIBRILLATOR WAS IMPLANTED PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED 16 DAYS LATER ON ASPIRIN AND PLAVIX. IN THE OPINION OF THE PHYSICIAN, THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE CARDIAC ARREST AND THE TAXUS STENT, AS WELL AS A POSSIBLE RELATIONSHIP BETWEEN THE CARDIAC ARREST AND THE PROCEDURE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORP. 3.5 X 24 MM 6043522

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R