BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2942563 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00626
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    August 17, 2010
    Report Date
    January 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA, ISCHEMIA, HYPERTENSION, AND MYOCARDIAL INFARCTION ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF A 3.0X18 PROMUS RX STENT ON 16 AUGUST 2010 IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, PRIOR TO (B)(6) 2012 THE PATIENT EXPERIENCED ANGINA, A POSSIBLE MYOCARDIAL INFARCTION, RECURRENT ISCHEMIC SYMPTOMS, NAUSEA, VOMITING, DIAPHORESIS, AND ELEVATED BLOOD PRESSURE. THERE WAS NO REPORT OF ANY TYPE OF MEDICAL INTERVENTION REPORTED FOR TREATMENT OF THESE SYMPTOMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46793 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0031961

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability