BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7999349 · Received October 24, 2018

    Report

    Report Number
    9612164-2018-02908
    Event Type
    Death
    Date Received
    October 24, 2018
    Date of Event
    October 31, 2017
    Report Date
    October 24, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: ¿SILENT¿ DIABETES AND CLINICAL OUTCOME AFTER TREATMENT WITH CONTEMPORARY DRUG-ELUTING STENTS THE BIO-RESORT SILENT DIABETES STUDY CLEMENS VON BIRGELEN, MD, PHD,A,B MARLIES M. KOK, MD,A NAVEED SATTAR, MD, PHD,C PAOLO ZOCCA, MD,A CEES DOELMAN, PHD,D GERT D. KANT, MD,E MARIJE M. LÖWIK, PHD,A LIEFKE C. VAN DER HEIJDEN, MD,A HANIM SEN, MD, PHD,A K. GERT VAN HOUWELINGEN, MD,A MARTIN G. STOEL, MD, PHD,A J. (HANS) W. LOUWERENBURG, MD,A MARC HARTMANN, MD, PHD,A FRITS H.A.F. DE MAN, MD, PHD,A GERARD C.M. LINSSEN, MD, PHD,F CARINE J.M. DOGGEN, PHD,B KENNETH TANDJUNG, MD, PHDA J A C C : CARDI O V AS C ULAR I NT E R V E N T IONS VOL. 11, NO. 5, 2018 ª 20 1 8 THE AU THORS. P U B L IS H E D B Y E L S E V I E R ON B E H A LF OF T HE AM E R I C AN COL LE GE OF CARD IOLOGY FOUNDA TION. THI S I S AN OPE N A C C ES S ART I C L E UNDE R HTTPS://DOI.ORG/10.1016/J.JCIN.2017.10.038. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OBJECTIVES THIS STUDY SOUGHT TO ASSESS THE PREVALENCE AND CLINICAL IMPACT OF SILENT DIABETES AND PRE-DIABETES IN ¿NONDIABETIC¿ PERCUTANEOUS CORONARY INTERVENTION (PCI) ALL-COMERS. BACKGROUND PATIENTS WITH UNDETECTED AND THUS UNTREATED (SILENT) DIABETES MAY HAVE HIGHER EVENT RISKS AFTER PCI WITH CONTEMPORARY DRUG-ELUTING STENTS (DES). METHODS THE BIO-RESORT SILENT DIABETES STUDY, PERFORMED AT THORAXCENTRUM TWENTE, IS A SUBSTUDY OF THE RANDOMIZED MULTICENTER BIO-RESORT (BIODEGRADABLE POLYMER AND DURABLE POLYMER DRUG-ELUTING STENTS IN AN ALL COMERS POPULATION) TRIAL (NCT01674803). PATIENTS UNDERWENT ORAL GLUCOSE TOLERANCE TESTING (OGTT), AND ASSESSMENT OF GLYCOSYLATED HEMOGLOBIN WITH FASTING PLASMA GLUCOSE. PRIMARY ENDPOINT WAS A COMPOSITE OF CARDIAC DEATH, TARGET VESSEL¿ RELATED MYOCARDIAL INFARCTION, OR TARGET VESSEL REVASCULARIZATION AT 1 YEAR. RESULTS OF THE 988 PARTICIPANTS, OGTT DETECTED SILENT DIABETES IN 68 (6.9%), PRE-DIABETES IN 133 (13.3%), AND NORMAL GLUCOSE METABOLISM IN 788 (79.8%). PATIENTS WITH SILENT DIABETES HAD HIGHER PRIMARY ENDPOINT RATES (13.2% VS. 7.6% VS. 4.8%; P 0.001; SILENT DIABETES VS. NORMAL: HAZARD RATIO: 4.2; 95% CONFIDENCE INTERVAL: 1.9 TO 9.2). DIFFERENCES WERE DRIVEN BY MYOCARDIAL INFARCTION (P 0.001) WHICH OCCURRED MOSTLY 48 H. BASED ON GLYCOSYLATED HEMOGLOBIN AND FASTING PLASMA GLUCOSE, SILENT DIABETES WAS FOUND IN 33 (3.3%) PATIENTS, PRE-DIABETES IN 217 (22.0%) PATIENTS, AND NORMAL GLUCOSE METABOLISM IN 738 (74.7%) PATIENTS; PRIMARY ENDPOINT RATES WERE SIMILAR TO OGTT-BASED ANALYSES (12.1% VS. 5.5% VS. 3.1%; P ¼ 0.01). MULTIVARIATE ANALYSES DEMONSTRATED THAT ABNORMAL GLUCOSE METABOLISM BY EITHER DIAGNOSTIC APPROACH, PRESENT IN 330 (33.4%) PATIENTS, INDEPENDENTLY PREDICTED ADVERSE EVENT RISK (HAZARD RATIO: 2.2; 95% CONFIDENCE INTERVAL: 1.2 TO 4.2). CONCLUSIONS ABNORMAL GLUCOSE METABOLISM WAS DETECTED IN 1 OF 3 ¿NONDIABETIC¿ PCI PATIENTS AND WAS INDEPENDENTLY ASSOCIATED WITH UP TO 4-FOLD HIGHER EVENT RISKS. FUTURE INTERVENTION TRIALS SHOULD DETERMINE WHETHER MEANINGFUL BENEFITS ACCRUE FROM ROUTINE GLYCEMIA TESTING IN SUCH PATIENTS. ADVERSE EVENTS REPORTED IN THE STUDY ARE DEATH, MI, TVR AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839000 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death