BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884711 · Received October 25, 2010

    Report

    Report Number
    2024168-2010-02248
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, A PROMUS 2.5 X 28 STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL TO MID SEGMENT OF THE DIAGONAL BRANCH AFTER PRE-DILATATION. ON (B)(6) 2010, THE PT PRESENTED WITH SEVERE CHEST PAIN. ON (B)(6) 2010, THROMBECTOMY OF THE PROMUS STENT WAS PERFORMED FOLLOWED BY DEPLOYMENT OF A VISION STENT. ANGIOGRAM SHOWED EXCELLENT RESULTS. THERE WAS NO REPORTED ADVERSE PT SEQUELA. REPORTEDLY, THE PT HAD RECENTLY BEEN TAKEN OFF ASPIRIN, PLAVIX, AND COUMADIN IN PREPARATION FOR EYE SURGERY. THOUGH REQUESTED, ADDITIONAL INFO WAS NOT 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 US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8121741

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R DIL CATH: APEX 2.0X20| 6 FR ANGIOSEAL| QUANTUM MAVERICK 3.5X15| WHISPER GUIDE WIRE| VOYAGER 2.0X15