BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2192204 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05514
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 26, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, MYOCARDIAL INFARCTION (MI), AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER 2 YEARS POST IMPLANTATION OF A 3.5 X 12 AND A 3.5 X 18/20 PROMUS STENT IN THE LEFT MAIN CORONARY ARTERY (LMCA) /CIRCUMFLEX (LCX), THE PATIENT WAS HOSPITALIZED WITH WORSENING CHEST PAIN RADIATING TO LEFT UPPER EXTREMITIES AND LEFT NECK. ENZYMES WERE ELEVATED AND THE EVENT WAS DIAGNOSED AS A MYOCARDIAL INFARCTION. ON (B)(6) 2011, ANGIOGRAM REVEALED 90% IN-STENT RESTENOSIS OF THE OSTIAL LCX. ON (B)(6) 2011, CORONARY ARTERY BYPASS SURGERY WAS PERFORMED. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT IS RECOVERING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R| S PROMUS STENT 3.5X12MM