BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 2881742 · Received December 20, 2012

    Report

    Report Number
    9612164-2012-01819
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    August 20, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (INCOMPLETE STENT APPOSITION, MI AND STENT THROMBOSIS). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (NO DEVICE OR PROCEDURAL IMAGES RETURNED FOR EVALUATION). CONCLUSION: UNABLE TO CONFIRM COMPLAINT (NO DEVICE OR PROCEDURAL IMAGES RETURNED FOR EVALUATION). KNOWN INHERENT RISK OF PROCEDURE (INCOMPLETE STENT APPOSITION, MI AND STENT THROMBOSIS). (B)(4). LITERATURE REFERENCE: "COMPARISON OF EARLY STRUT COVERAGE BETWEEN ZOTAROLIMUS- AND EVEROLIMUS-ELUTING STENTS USING OPTICAL COHERENCE TOMOGRAPHY- 0002-9149/12/ - SEE FRONT MATTER _ 2012 ELSEVIER INC. ALL RIGHTS RESERVED. WWW.AJCONLINE.ORG.

    Description of Event or Problem · 1

    THERE HAVE BEEN NO OPTICAL COHERENCE TOMOGRAPHIC (OCT) DATA DIRECTLY COMPARING THE PATTERN OF STRUT COVERAGE BETWEEN THE 2 SECOND-GENERATION DRUG-ELUTING STENTS IN THE EARLY PERIOD. THE AIM OF THIS PROSPECTIVE STUDY WAS TO EVALUATE EARLY STRUT COVERAGE USING OPTICAL COHERENCE TOMOGRAPHY 3 MONTHS AFTER RESOLUTE ZOTAROLIMUS-ELUTING STENT (ZES-R) OR EVEROLIMUS-ELUTING STENT (EES) IMPLANTATION IN DE NOVO CORONARY ARTERY LESIONS. A TOTAL OF 40 PATIENTS WHO WERE SUITABLE FOR THE OCT PROCEDURE AND CONSENTED TO THE STUDY PROTOCOL WERE RANDOMIZED 1:1 TO RECEIVE EITHER ZES-R OR EES. AMONG THESE PATIENTS, 35 STENTED LESIONS (18 ZES-R, 17 EES) IN 34 PATIENTS WERE EVALUATED BY OPTICAL COHERENCE TOMOGRAPHY IMMEDIATELY AND 3 MONTHS AFTER STENT IMPLANTATION. NEO-INTIMAL HYPERPLASIA THICKNESS, PERCENTAGE OF UNCOVERED STRUTS, AND THE PROPORTION OF MALPOSED STRUTS WERE MEASURED AT 1-MM INTERVALS. AN UNCOVERED STRUT WAS DEFINED AS HAVING A NEO-INTIMAL HYPERPLASIA THICKNESS OF 0 MM. AT THE 3-MONTH OCT EVALUATION, MEAN NEO-INTIMAL HYPERPLASIA THICKNESS AND MEAN PERCENTAGE OF UNCOVERED STRUTS WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE GROUPS. THE PERCENTAGE OF MALPOSED STRUTS WAS ALSO SIMILAR BETWEEN THE GROUPS. THROMBI WERE DOCUMENTED IN 3 STENTS. IN CONCLUSION, EARLY STENT STRUT COVERAGE ON THE BASIS OF SERIAL OCT EVALUATION WAS COMPARABLE BETWEEN ZES-R AND EES 3 MONTHS AFTER STENT IMPLANTATION. ALSO, THE PROPORTION OF ACUTE CORONARY SYNDROMES OR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION WAS HIGHER IN THE RESOLUTE OCT SUBSTUDY. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR