BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2437254 · Received February 2, 2012

    Report

    Report Number
    2024168-2012-00618
    Event Type
    Death
    Date Received
    February 2, 2012
    Date of Event
    June 26, 2011
    Report Date
    January 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, DUE TO UNSTABLE ANGINA, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF ONE 3.0X12 PROMUS STENT TO THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. POST PROCEDURAL RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW IN THE TREATED LESION. ON (B)(6) 2010, THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF CLOPIDOGREL 600 MG. ON (B)(6) 2010, THE PATIENT BEGAN CLOPIDOGREL 75 MG DOSING AND WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT DIED. CAUSE OF DEATH IS UNKNOWN AND AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE CAUSE OF DEATH WAS ACUTE PULMONARY FIBROSIS AND RESPIRATORY FAILURE. AN AUTOPSY WAS NOT REQUESTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0071541

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death