BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4233401 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07277
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    November 27, 2013
    Report Date
    October 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE IS NOT BEING RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. 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) 2009, THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE POSTERIOR LATERAL ARTERY. PRE-DILATATION WAS PERFORMED USING AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC). THE 2.5X18MM PROMUS AND 3.0X18MM PROMUS STENT IMPLANTS WERE SUCCESSFULLY DEPLOYED WITHOUT ANY REPORTED DEVICE OR PROCEDURE ISSUES. THE PATIENT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2011, THE PATIENT EXPERIENCED ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). ON (B)(6) 2013, THE PATIENT EXPERIENCED A STROKE AND WAS HOSPITALIZED; HOWEVER THE PATIENT EXPIRED THE SAME DAY. PER THE DEATH CERTIFICATE, THE DEATH WAS DUE TO COPD, CARDIOPULMONARY ARREST, RESPIRATORY FAILURE, AND, ATHEROSCLEROTIC HEART DISEASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713959 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death STENT: 3.0X18MM PROMUS