BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1894992 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02363
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO. THE OTHER UNK RX PROMUS REFERENCED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). STENTS: PROMUS RX 2.5 X 23; PROMUS RX 2.75 X 28; PROMUS RX 3.0 X 08. THERE WAS NO REPORTED PRODUCT DEFICIENCY. MYOCARDIAL INFARCTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. 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. THE PROMUS RX 3.0 X 08 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INTIAL MDR FILING, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE FOUR STENTS IMPLANTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, DUE TO A POSITIVE STRESS TEST, THE PATIENT UNDERWENT THE DEPLOYMENT OF TWO DRUG ELUTING STENTS (PROMUS) TO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE FIRST OBTUSE MARGINAL BRANCH. POST-STENT DEPLOYMENT RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW IN THE TREATED LESIONS. THE PATIENT DID NOT RECEIVE A PERI-PROCEDURAL LOADING DOSE OF A THIENOPYRIDINE TREATMENT DURING THE INDEX PROCEDURE. ON (B)(6) 2010, ONE DAY POST INDEX PROCEDURE AND DURING INDEX HOSPITALIZATION, THE PATIENT WAS REPORTED TO HAVE POST PROCEDURE CARDIAC ENZYME ELEVATIONS INDICATING A POST PROCEDURE MYOCARDIAL INFARCTION. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THIS EVENT AND WAS DISCHARGED ON (B)(6) 2010 IN STABLE CONDITION. THE INTENSITY AND EVENT RELATIONSHIP TO THE STUDY DRUG, THE STUDY DEVICE, AND THE STUDY PROCEDURE WERE NOT PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE U.S.

    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 NA 0061141

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability UNKNOWN RX PROMUS