BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1842125 · Received September 20, 2010

    Report

    Report Number
    2024168-2010-01963
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES, CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE IT WAS NOTED THAT THE GUIDE WIRE EXIT PORT WAS KINKED, BUT THE KINK WAS FIXED AND THE PROMUS STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED OVER THE GUIDE WIRE. THE PROXIMAL END OF THE GUIDE WIRE GOT CAUGHT WITH THE GUIDE WIRE EXIT PORT OF THE PROMUS SDS AND THERE WAS RESISTANCE NOTED, BUT THE PROMUS STENT DID CROSS THE LESION; HOWEVER, DURING AN ATTEMPT TO DEPLOY THE STENT, THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE IS A POSSIBILITY THAT THE AIR ENTERED THE INFLATION LUMEN AND RESULTED IN DECREASED HEART RATE AND SLOW FLOW. THE PATIENT'S HEART RATE DECREASED AND THERE WAS SLOW BLOOD FLOW NOTED UNDER ANGIOGRAPHY. THE PATIENT'S CONDITION WAS STABILIZED AND A NON ABBOTT STENT WAS USED TO TREAT THE LESION. REPORTEDLY, THERE WAS NO PRE-DILATATION OR POST DILATATION PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES, CLONMEL NA 0012541

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: HEARTRAIL 6F IL3.5SH| GUIDE WIRE: SION| STENT: TAXUS 3.0 X 24