BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2232044 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06108
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST PROMUS STENT IMPLANTATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD), THERE WAS A 10% RESIDUAL STENOSIS. APPROXIMATELY 11 MONTHS POST PROMUS STENT IMPLANTATION, THE PATIENT EXPERIENCED NON-ISCHEMIC CHEST PAIN. ANGIOGRAM SHOWED 20% IN-STENT STENOSIS. NO TREATMENT WAS PROVIDED. ON (B)(6) 2011, THE PAIN RESOLVED AND THE PATIENT WAS DISCHARGED. 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 0012861

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O