BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3092540 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02763
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, DYSPNEA, ISCHEMIA, MYOCARDIAL INFARCTION AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM 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, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE 4.0 X 18 MM PROMUS REFERENCED IN IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE 4.0 X 18 MM PROMUS STENT AND THE 3.5 X 12 MM PROMUS STENT WERE IMPLANTED IN THE OBTUSE MARGINAL 1 (OM1) VESSEL, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2013, THE PATIENT WAS ADMITTED PALPITATIONS, SHORTNESS OF BREATH, AND CHEST PAIN, SUBSTERNAL, RADIATING TO THE RIGHT SHOULDER. THE PATIENT WAS RULED OUT FOR MYOCARDIAL INFARCTION. IT WAS DETERMINED THAT THE PATIENTS EPISODE WAS MOST LIKELY RELATED TO AN OVERAGGRESSIVE SENSOR AND THIS CORRECTED BY DEACTIVATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT PRESENTED WITH RECURRENT ISCHEMIC SYMPTOMS WITH A MYOCARDIAL INFARCTION. THE PATIENT EXPERIENCED MID-STERNAL CHEST PAIN WITH RADIATION TO THE BACK AND SHOULDERS, AND SHORTNESS OF BREATH. ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2013. IT WAS CONFIRMED THAT THE PATIENT HAD A MYOCARDIAL INFARCTION; HOWEVER, THERE WAS NO STENT THROMBOSIS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013 IN STABLE CONDITION ON MEDICAL THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194573 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9070241

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R| S STENT: 4.0 X 18 MM PROMUS