BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1890307 · Received October 22, 2010

    Report

    Report Number
    2024168-2010-02222
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE TORTUOUS LEFT ANTERIOR DESCENDING ARTERY, MULTIPLE PRE-DILATATIONS WERE PERFORMED USING A NON-ABBOTT DILATATION CATHETER, HOWEVER, THE VESSEL WAS NON-COMPLIANT AND THE BALLOON ASSUMED THE SHAPE OF THE VESSEL. A 2.5 X 28 PROMUS STENT SYSTEM WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED UNSPECIFIED STENT THAT WAS S SHAPED. THE STENT SYSTEM COULD NOT ADVANCE THROUGH THE STENT AND WHEN REMOVING THE STENT SYSTEM, THE STENT BECAME CAUGHT ON THE GUIDE CATHETER CAUSING A STENT STRUT TO FLARE. THE STENT SYSTEM WAS REMOVED SUCCESSFULLY FROM THE ANATOMY. AN ATTEMPT WAS MADE TO ADVANCE A 2.5 X 23 PROMUS STENT SYSTEM AND THE SAME OCCURRED. THE STENT SYSTEM WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. AN ATTEMPT WAS MADE TO ADVANCE A 2.5 X 18 PROMUS STENT SYSTEM; HOWEVER, FORCE WAS APPLIED AND THE SHAFT SEPARATED AT THE TUOHY VALVE OUTSIDE THE ANATOMY. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. A GUIDE EXTENSION WAS PLACED FOLLOWED BY SUCCESSFUL ADVANCEMENT AND DEPLOYMENT OF TWO 2.5 X 18 PROMUS STENTS. THERE WAS NO REPORTED ADVERSE PT EFFECTS. REPORTEDLY, THE PHYSICIAN BELIEVES THE DIFFICULTIES EXPERIENCED WERE ANATOMY RELATED AND NOT DEVICE RELATED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP 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 NA 0012861

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 2.5X18 PROMUS STENTS (X2)| GUIDELINER:| GUIDE CATH: RUNWAY