BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1951091 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00049
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    July 14, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: FORTE FLOPPY; DILATATION CATHETER: APEX; GUIDING CATHETER: CORDIS SHINOBI.THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION (MI), AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO STAGE PROCEDURE. THE FIRST PROCEDURE WAS PERFORMED IN (B)(6), DURING WHICH THE PATIENT WAS IMPLANTED WITH THREE NON-ABBOTT STENTS IN THE MID AND DISTAL RIGHT CORONARY ARTERY. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT UNDERWENT THE SECOND PROCEDURE TO TREAT THE LEFT CIRCUMFLEX ARTERY, DURING WHICH ONE 2.75 X 15 MM PROMUS STENT WAS IMPLANTED. POST PROCEDURE, ON (B)(6) 2010, THE PATIENT DEVELOPED AN INCREASE IN CARDIAC ENZYMES CONSISTENT WITH A MYOCARDIAL INFARCTION. NO TREATMENT WAS PERFORMED AND THE EVENT RESOLVED ON (B)(6) 2010 WITHOUT RESIDUAL EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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 58 YR Disability