BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7991199 · Received October 22, 2018

    Report

    Report Number
    9612164-2018-02861
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    October 23, 2017
    Report Date
    October 22, 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

    AVERAGE AGE. AVERAGE GENDER. DATE ARTICLE WAS ACCEPTED. JOURNAL ARTICLE: "CLINICAL OUTCOMES OF COMPLEX REAL-WORLD DIABETIC PATIENTS TREATED WITH AMPHILIMUS SIROLIMUS-ELUTING STENTS OR ZOTAROLIMUS-ELUTING STENTS: A SINGLE-CENTER REGISTRY." RIK ROZEMEIJER A, DANIELA BENEDETTO A, ADRIAAN O. KRAAIJEVELD A, MICHIEL VOSKUIL A, MÈRA STEIN A, LEO TIMMERS A, SASKIA Z. RITTERSMA A, PIERFRANCESCO AGOSTONI A,B, PIETER A. DOEVENDANS A,C, PIETER R. STELLA CARDIOVASCULAR REVASCULARIZATION MEDICINE 19 (2018) 521¿525 HTTPS://DOI.ORG/10.1016/J.CARREV.2017.10.011 1553-8389/© 2017 ELSEVIER INC. ALL RIGHTS RESERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OBJECTIVE: TO ASSESS CLINICAL OUTCOMES OF AMPHILIMUS SIROLIMUS-ELUTING STENTS (A-SES) AS COMPARED TO ZOTAROLIMUS-ELUTING STENTS (ZES) IN COMPLEX REAL-WORLD DIABETIC PATIENTS. BACKGROUND: PATIENTS WITH DIABETES MELLITUS REPRESENT ONE OF THE MOST CHALLENGING SCENARIOS WITH HIGH RATES OF RESTENOSIS AND STENT THROMBOSIS IN THE CURRENT ERA OF DRUG-ELUTING STENTS. HENCE, WE ASSESSED THE SAFETY OF A-SES VERSUS ZES IN COMPLEX DIABETIC PATIENTS. METHODS: IN THIS OBSERVATIONAL STUDY, WE ANALYZED ALL CONSECUTIVE PATIENTS WITH DIABETES MELLITUS REFERRED TO OUR CENTER FROM NOVEMBER 2012 TO NOVEMBER 2014. THE PRIMARY OUTCOME WAS TARGET-LESION FAILURE AT 1-YEAR FOLLOW-UP. RESULTS: A TOTAL OF 165 CONSECUTIVE DIABETIC PATIENTS UNDERWENT PERCUTANEOUS CORONARY INTERVENTION WITH A-SES OR ZES FOR STABLE CORONARY ARTERY DISEASE IN OUR TERTIARY CENTER. USING THE KAPLAN MEIER METHOD THE CUMULATIVE INCIDENCE OF TARGET-LESION FAILURE WAS 6.7% (5.9% A-SES VERSUS 7.5% ZES, P = 0.19) AT 1-YEAR FOLLOW-UP. EVENT-FREE SURVIVAL AT 1 YEAR FOLLOW-UP WAS SIMILAR (89.4% A-SES VS. 83.3% ZES, P = 0.29). INTERESTINGLY, WE DID NOT FIND ANY CASES OF DEFINITE-, AND ONLY ONE CASE OF PROBABLE STENT THROMBOSIS IN THIS HIGH RISK COHORT. CONCLUSION: IN THIS REAL-WORLD REGISTRY, A-SES AND ZES SEEMS TO BE ASSOCIATED WITH PROMISING 1-YEAR CLINICAL SAFETY OUTCOMES FOLLOWING PCI IN A CONTEMPORARY COHORT OF HIGH-RISK DIABETIC PATIENTS. OUR RESULTS SHOULD BE CONSIDERED HYPOTHESIS GENERATING, AS THE CLINICAL SAFETY OF A-SES HAS TO BE CONFIRMED IN A LARGE TRIAL. THE DEVICE USED WAS RESOLUTE INTEGRITY AND ADVERSE EVENTS REPORTED WERE MI, TVR, STENT THROMBOSIS, GI BLEED, AND OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832429 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention