BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2250379 · Received September 15, 2011

    Report

    Report Number
    2024168-2011-06332
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    May 10, 2011
    Report Date
    August 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IF THE RASH RECURS AFTER STOPPING THE PREDNISONE, IT MAY BE NECESSARY TO DISCONTINUE THE PATIENTS CURRENT ASPIRIN OR PLAVIX REGIME. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. THE FIVE ADDITIONAL PROMUS STENTS ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. 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. HYPERSENSITIVITY (ALLERGIC REACTIONS) IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE AS IT WAS REPORTED THAT TWO WEEKS AFTER THE PROMUS STENTS WERE IMPLANTED ON (B)(6) 2011, THE PATIENT DEVELOPED A RASH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD SEVERAL STENTS IMPLANTED PREVIOUSLY; ONE IN 2002, AN UNCERTAIN AMOUNT IN 2008, AND A TOTAL OF SIX PROMUS STENTS IN 2011. ON (B)(6) 2011, TWO PROMUS STENTS WERE IMPLANTED IN THE PATIENT. AN UNSPECIFIED PROMUS STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY AND A 3.0 X 15 MM PROMUS STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. TWO WEEKS AFTER THE STENTS WERE IMPLANTED, THE PATIENT DEVELOPED A RASH SUSPECTED TO BE CAUSED BY THE PROMUS STENTS. THE RASH WAS DESCRIBED AS A PRURITIC RASH ON THE TRUNK AND PROXIMAL ARMS, WITH LESS INVOLVEMENT ON THE BACK AND THE LOWER EXTREMITIES. THE PATIENT HAD BEEN ON SIMVASTATIN AND THIS WAS DISCONTINUED DUE TO SUSPICION THAT IT MAY BE RESPONSIBLE FOR THE RASH. THE PATIENT HAD FOUR SKIN BIOPSIES DONE ON (B)(6) OF 2011, WHICH SHOWED A (B)(6) AND (B)(6), MOST COMPATIBLE WITH A LICHENOID DRUG ERUPTION. THE PATIENT HAD BEEN ON DESOXIMETASONE CREAM, BUT THIS WAS DISCONTINUED AND THE PATIENT WAS STARTED ON PREDNISONE 40 MG DAILY ON (B)(6) 2011, REDUCED TO 20 MG AFTER THE FIRST FIVE DAYS, WITH A FURTHER PLANNED REDUCTION ON (B)(6) 2011. THE PATIENT HAS BEEN TOLD THAT IF ANY FURTHER SYMPTOMS OF CORONARY INSUFFICIENCY DEVELOP, FURTHER STENTING IS NOT POSSIBLE AND THAT CORONARY ARTERY BYPASS GRAFTING (CABG) WOULD BE NEEDED. THE PATIENT HAD PREVIOUSLY DECLINED CABG. THE PATIENT HAS NO HISTORY OF SKIN CANCER, MELANOMA, SUSPICIOUS MOLES, ECZEMA, PSORIASIS OR OTHER MAJOR SKIN DISEASE. THE PATIENT IS TO RESUME THE DESOXIMETASONE CREAM 0.25% TWICE DAILY TO THE RASH AND COMPLETE THE PREDNISONE COURSE.

    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 76 YR Other STENT: PROMUS (X5)