BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2233569 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06135
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE HOSPITALIZATION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST PROMUS STENT IMPLANTATION IN THE LEFT MAIN CORONARY ARTERY, THE PATIENT EXPERIENCED DIZZINESS, LIGHTHEADEDNESS, NUMBNESS AND TINGLING CAUSED BY ORTHOSTATIC HYPOTENSION. THE PATIENT WAS HOSPITALIZED AND IS BEING EVALUATED FOR ACUTE CORONARY SYNDROME. THE STATUS OF THE PROMUS STENT WAS THOUGHT TO BE PATENT, BUT WAS NOT CONFIRMED. ETIOLOGY OF THE ORTHOSTATIC HYPOTENSION IS UNKNOWN. 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 9073161

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization