BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932287 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02805
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    May 10, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS. PREDILATATION WAS PERFORMED PRIOR TO PLACEMENT OF THE PROMUS STUDY STENT. LESION STENOSIS AFTER STENTING WAS 0%. SUBJECT WAS DISCHARGED, (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2010, 318 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPIRED AT HOME. NO AUTOPSY WAS PERFORMED. PER THE DEATH CERTIFICATE, CAUSE OF DEATH WAS CARDIOPULMONARY ARREST. NO ADDITIONAL INFORMATION OR PATIENT EFFECTS NOTED. (B)(4).

    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 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death