BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3050735 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02169
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    December 8, 2012
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND MYOCARDIAL INFARCTION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE OTHER DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. 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) 2011, THE PATIENT UNDERWENT STENTING WITH TWO PROMUS CORONARY STENTS. ON (B)(6) 2012, THE PATIENT MAY HAVE HAD A MYOCARDIAL INFARCTION WITH RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR GREATER. THE RESULTS OF THE CARDIAC ENZYMES AND ECHOCARDIOGRAM ARE UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149062 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability STENT: PROMUS