BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2870942 · Received December 12, 2012

    Report

    Report Number
    2024168-2012-07883
    Event Type
    Death
    Date Received
    December 12, 2012
    Date of Event
    September 17, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT: XIENCE V 4.0 X 18 AND 2.75 X 12; CLOPIDOGREL, ASPIRIN. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA, DEATH, AND MYOCARDIAL INFARCTION ARE LISTED IN THE ELECTRONIC 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. 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) 2008, THE PATIENT UNDERWENT STENTING IN THE FIRST OBTUSE MARGINAL CORONARY ARTERY WITH ONE XIENCE V STENT (2.75X12) AND IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH ONE XIENCE V STENT (4.0X18). ON (B)(6) 2008, THE PATIENT UNDERWENT A STAGED PROCEDURE IN THE PROXIMAL RIGHT POSTERIOR DESCENDING CORONARY ARTERY WITH ONE PROMUS STENT (2.5X15). ON (B)(6) 2012, THE PATIENT WENT TO THE EMERGENCY ROOM WITH CHEST PAIN THAT WAS DIAGNOSED AS AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT RECEIVED A STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND THE PROXIMAL RCA. THE PATIENT BECAME HYPOXIC, RESTLESS, AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, BUT WAS UNSUCCESSFUL. THE PATIENT WAS PRONOUNCED DEAD ON (B)(6) 2012. THERE WAS NO ADDITIONAL INFORMATION.

    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 54 YR Death SEE H10 FOR CONCOMITANT MEDICAL DEVICES