BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2223711 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05946
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. 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. DEATH, MYOCARDIAL INFARCTION, RESTENOSIS, AND HEMORRHAGE ARE KNOWN ADVERSE EVENTS 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, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST STENTING PROCEDURE IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH ONE PROMUS 3.5 X 18 MM STENT AND IN THE LEFT CIRCUMFLEX WITH ONE 2.75 X 32 NON-ABBOTT STENT, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION ON (B)(6) 2011 AND EXPIRED AT HOME ON (B)(6) 2011. UPON AUTOPSY IT WAS NOTED THAT THERE WAS NARROWING IN THE MAIN CORONARY ARTERY (25%), THE RIGHT CORONARY ARTERY (RCA 50-75%) AND THE LAD (90%). ADDITIONALLY, THE LAD SHOWED SEVERE ATHEROSCLEROSIS WITH CALCIFIED STENTED SEGMENT WITH 95% OCCLUSION. MICROSCOPIC DESCRIPTION IN THE AUTOPSY REPORT NOTES LAD, LEFT CIRCUMFLEX (LCX) AND RCA TO HAVE A VARIABLE SIZED ATHEROSCLEROTIC PLAQUES OCCLUDING THE LUMEN UP TO 95% AND AN AREA OF CORONARY STENT IDENTIFIED AND THERE "APPEARS TO BE A HEMORRHAGE INTO THE STENT", NO STENT THROMBOSIS. THE AUTOPSY FINAL ANATOMIC DIAGNOSIS WAS ACUTE MYOCARDIAL INFARCTION WITH AREAS OF PREVIOUS INTERSTITIAL FIBROSIS AND CORONARY ATHEROSCLEROSIS WITH 95% OCCLUSION OF THE STENT AREA AND 90-95% NARROWING OF THE LAD, LCX AND RCA. THERE WAS NO ADDITIONAL INFORMATION 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 8092941

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death STENT: TAXUS 2.75 X 32 MM