BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3450659 · Received November 5, 2013

    Report

    Report Number
    2024168-2013-07099
    Event Type
    Death
    Date Received
    November 5, 2013
    Date of Event
    June 27, 2013
    Report Date
    October 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE ROUNDED, REPORTED AS 65.6 +/- 11.4 YEARS. SEX REPORTED AS MALE, 125/189, 66.7%. DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATE BASED ON DATE OF PUBLICATION. DEATH CLASSIFICATION ON FOLLOW UP: NO 96.0%; NONCARDIAC 2.0%; UNKNOWN 0.7%; CARDIAC SUDDEN DEATH PROBABLE 0.6%; CARDIAC NONSTENT THROMBOSIS 0.7%. ACUTE NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI), NONFATAL 1.6%; ACUTE STEMI NONFATAL 2.6%. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO REPORTED PRODUCT DEFICIENCIES AND THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICES IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ARTICLE ATTACHED: OUTCOMES OF PATIENTS TREATED WITH THE EVEROLIMUS- VERSUS THE PACLITAXEL-ELUTING STENTS IN A CONSECUTIVE COHORT OF PATIENTS AT A TERTIARY MEDICAL CENTER THE UNK XIENCE REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER. 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

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW: IN THIS (B)(4) STUDY, WE COMPARE NON-ABBOTT PACLITAXEL-ELUTING STENTS (PES) WITH XIENCE (PROMUS) EVEROLIMUS ELUTING STENTS (EES) FOR LATE OUTCOME AT 2 YEARS IN AN UNSELECTED CONSECUTIVE GROUP OF PATIENTS AT A SINGLE TERTIARY MEDICAL CENTER. BOTH DE NOVO AND RESTENOTIC LESIONS WERE INCLUDED. FOLLOW-UP WAS AT 2 YEARS FROM THE INDEX PROCEDURE USING MEDICAL RECORDS, PHONE CALLS, OR BOTH. AT 2 YEARS, FOLLOW-UP WAS COMPLETED FOR 82.3% OF ALL PATIENTS ENROLLED (PROMUS 92.9% AND NON-ABBOTT PES 71.5%). A TOTAL OF 159 PES PATIENTS (322 VESSELS, 602 SEGMENTS) AND 189 EES PATIENTS (304 VESSELS, 476 SEGMENTS) WERE INCLUDED IN THE FINAL ANALYSIS. OF THE 189 EES PATIENTS, CLINICAL OUTCOMES WERE AS FOLLOWS: TARGET LESION REVASCULARIZATION (TLR) PER SEGMENT (9.5%). TLR PER VESSEL (12.6%). TLR PER PATIENT (17.2%). TARGET VESSEL REVASCULARIZATION (TVR) PER SEGMENT (11.9%). TVR PER VESSEL (18.3%). TVR PER PATIENT (26.5%). TARGET LESION FAILURE (21.5%); TLR 17.2%, CARDIAC DEATH 3.7%, NONFATAL MYOCARDIAL INFARCTION (MI) 4.3%. TARGET VESSEL FAILURE (30.7%). STENT THROMBOSIS: DEFINITE OR PROBABLE 0.0%, POSSIBLE 1.1%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569767 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death