BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1872446 · Received October 12, 2010

    Report

    Report Number
    2024168-2010-02140
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE REPORTED APPEARANCE OF AN OVERSIZED BALLOON INFLATION PROFILE MAY BE THE RESULT OF, BUT NOT LIMITED TO MFG, HIGH INFLATION PRESSURES USED AT STENT DEPLOYMENT, LESION CALCIFICATION, INCORRECT VESSEL DIAMETER SIZE MEASUREMENT, INCORRECT MARKER BAND PLACEMENT, IMPROPER PREPARATION OF THE DEVICE, SUCH THAT AIR IS WITHIN THE BALLOON OR INCORRECT PRODUCT SIZE SELECTION. RETURN OF THE PROMUS STENT DELIVERY SYSTEM MAY HAVE AIDED IN THE EVAL AND DETERMINATION OF CAUSE. ALTHOUGH THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY, A CONCLUSIVE CAUSE FOR THE REPORTED OVERSIZED BALLOON COULD NOT BE DETERMINED. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MFG LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION ONLINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OSTIAL LEFT ANTERIOR DESCENDING TO THE LEFT MAIN ARTERY. THERE WAS 75% STENOSIS, MILD TO MODERATE CALCIFICATION, BUT NO TORTUOUSITY. THE VESSEL WAS PREDILATED WITH A NON ABBOTT BALLOON AT 20 ATMOSPHERE (ATM) AND THE PROMUS STENT WAS DEPLOYED AT 16 ATM. REPORTEDLY, THE BALLOON EXPANDED ON THE PROXIMAL END MORE THAN EXPECTED OUTSIDE OF THE STENT. THE CASE WAS COMPLETED WITH THE PROMUS STENT. THERE WERE NOT ADVERSE PT EFFECTS. NO ADD'L INFO 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: 3.5X15 NC QUANTUM MR