BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 2721009 · Received August 30, 2012

    Report

    Report Number
    9612164-2012-01344
    Event Type
    Death
    Date Received
    August 30, 2012
    Report Date
    August 3, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS: OTHER (ROOT CAUSE COULD NOT BE DETERMINED, LIMITED INFORMATION) (INHERENT RISK OF PROCEDURE, DEATH, STENT THROMBOSIS AND MI) EVALUATION CODES: CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (INHERENT RISK OF PROCEDURE, DEATH, STENT THROMBOSIS AND MI) UNABLE TO CONFIRM COMPLAINT (ROOT CAUSE COULD NOT BE DETERMINED, LIMITED INFORMATION). (B)(4). BARE-METAL STENTS VERSUS DRUG-ELUTING STENTS IN LARGE (3.5MM) SINGLE CORONARY ARTERY: ANGIOGRAPHIC AND CLINICAL OUTCOMES AT 6 MONTHS JOURNAL OF CARDIOLOGY (2009) 54, 108-114

    Description of Event or Problem · 1

    THIS JOURNAL ARTICLE IS EXAMINING BARE-METAL STENTS VERSUS DRUG-ELUTING STENTS IN LARGE (3.5MM) SINGLE CORONARY ARTERY WITH ANGIOGRAPHIC AND CLINICAL OUTCOMES PERFORMED AT 6 MONTHS. SINCE SIROLIMUS-ELUTING AND PACLITAXEL-ELUTING STENTS WERE INTRODUCED AND APPROVED BY THE US FOOD AND DRUG ADMINISTRATION (FDA) IN 2003-2004, BARE-METAL STENTS (BMS) HAVE BEEN RAPIDLY REPLACED BY DRUG-ELUTING STENTS (DES). MANY LARGE RANDOMIZED TRIALS HAVE DEMONSTRATED THAT DES MARKEDLY REDUCE RESTENOSIS AND IMPROVE THE RATE OF EVENT FREE SURVIVAL. HOWEVER, THE FREQUENCY OF MYOCARDIAL INFARCTION AND SURVIVAL RATES HAS NOT DECREASED WITH DES. FURTHERMORE, THE ADVANTAGES OF DES OVER BMS HAVE NOT BEEN CONFIRMED FOR LARGER CORONARY ARTERIES; LARGER CORONARY ARTERIES CAN ADAPT TO INTIMAL HYPERPLASIA, AND THE NEED FOR REPEAT TARGET-LESION REVASCULARIZATION IS DECREASED. NEVERTHELESS, THE UTILIZATION OF DES HAS BEEN WIDESPREAD, REGARDLESS OF THE VESSEL SIZE, AND CONCERNS WITH REGARD TO THEIR LONG-TERM SAFETY AND COST HAVE BEEN RAISED. WE INVESTIGATED THREE TYPES OF DES AND A TYPE OF COBALT-CHROMIUM BMS (DRIVER; MEDTRONIC) WITH REGARD TO THE 6-MONTH CLINICAL AND ANGIOGRAPHIC OUTCOMES FOR SINGLE LARGE (3.5MM) VESSEL INTERVENTIONS. FROM (B)(6) 2002 TO (B)(6) 2007, A DATABASE OF PATIENTS WAS COLLECTED AT THE CARDIOVASCULAR CENTER OF (B)(6) HOSPITAL. PATIENTS WHO WERE TREATED FOR LARGE (3.5MM) SINGLE DE NOVO LESIONS LOCATED IN A NATIVE CORONARY VESSEL RESULTING IN STENOSIS OF 70-99% OF THE LUMINAL DIAMETER WAS ENROLLED IN THE STUDY. SUBJECTS HAD A HISTORY OF STABLE OR UNSTABLE ANGINA AND ALL RECEIVED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TYPES OF DES WERE: SIROLIMUS-ELUTING STENT, PACLITAXEL-ELUTING STENT AND ZOTAROLIMUSELUTING STENT (ENDEAVOR; MEDTRONIC) AND THE TYPE OF BMS WAS THE COBALT-CHROMIUM STENT (DRIVER; MEDTRONIC). THE MAJOR EXCLUSION CRITERIA WERE ACUTE ST SEGMENT ELEVATION MYOCARDIAL INFARCTION OR ACUTE NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, UNDERLYING STRUCTURAL HEART DISEASE INCLUDING HYPERTROPHIC CARDIOMYOPATHY, PREVIOUS BYPASS GRAFT SURGERY, A SERUM CREATININE LEVEL OF MORE THAN 2.0 MG/DL, AGE UNDER (B)(6), CONTRAINDICATION OR ALLERGY TO ANTIPLATELET AGENTS OR CONTRAST MEDIUM, LIFE EXPECTANCY OF LESS THAN 1 YEAR, AND OTHER SERIOUS MEDICAL CONDITIONS. A TOTAL OF 240 PATIENTS WERE SELECTED FOR THE STUDY; 196 PATIENTS WERE TREATED WITH DES AND 44 PATIENTS WERE TREATED WITH A BMS. THE FINDINGS FROM THE PRESENT STUDY SHOWED THAT THE DES AND THE COBALT-CHROMIUM BMS WHEN PLACED IN A LARGE SINGLE CORONARY ARTERY, SHOWED EQUALLY FAVORABLE 6-MONTH CLINICAL OUTCOMES, ALTHOUGH THE 6-MONTH ANGIOGRAPHIC RESULTS WERE MORE FAVOURABLE IN THE DES GROUP THAN IN THE BMS GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASPIRIN AND CLOPIDOGREL