BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 10776737 · Received November 3, 2020

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    Report

    Report Number
    9612164-2020-04200
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    July 4, 2020
    Report Date
    November 3, 2020
    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: NEW-GENERATION DRUG-ELUTING CORONARY STENTS IN OCTOGENARIANS: PATIENT-LEVEL POOLED ANALYSIS FROM THE TWENTE I-IV TRIALS AUTHORS: ELINE H. PLOUMEN, ROSALY A. BUITEN, CARINE J. M. DOGGEN, MARTIN G. STOEL, K. GERT VAN HOUWELINGEN, CARL E. SCHOTBORGH, GILLIAN A. J. JESSURUN, ARIEL ROGUIN, PETER W. DANSE, EDOUARD BENIT, ADEL AMINIAN, GERARD C. M. LINSSEN, FRITS H. A. F. DE MAN, MARC HARTMANN, DIEDRIK G. BUITEN, MARLIES M. KOK, PAOLO ZOCCA AND CLEMENS VON BIRGELEN JOURNAL: AMERICAN HEART JOURNAL YEAR: 2020 REFERENCE: DOI.ORG/10.1016/J.AHJ.2020.07.003 THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH EVENTS. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH A MEDTRONIC DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED. THE AIM OF THE STUDY WAS TO ASSESS THE 1-YEAR CLINICAL OUTCOME OF OCTOGENARIANS TREATED WITH NEW-GENERATION DES VERSUS YOUNGER PATIENTS. PATIENT LEVEL DATA OF 9,204 PARTICIPANTS FROM FOUR RANDOMIZED TRIALS (TWENTE, DUTCH PEERS, BIO-RESORT AND BIONYX (TWENTE I-IV) WAS POOLED. A TOTAL OF 671 PATIENTS WERE OCTOGENARIANS. RESOLUTE INTEGRITY AND RESOLUTE ONYX WERE AMONG THE NEW-GENERATION DES DEVICES USED. CLINICAL OUTCOMES AT THE 1 YEAR FOLLOW-UP INCLUDED ANY DEATH, CARDIAC DEATH, ANY MI, INCLUDING TARGET VESSEL MI AND PERIPROCEDURAL MI, ANY REVASCULARIZATION, INCLUDING TARGET VESSEL REVASCULARIZATION AND TARGET LESION REVASCULARIZATION, TARGET VESSEL FAILURE, DEFINITE OR PROBABLE STENT THROMBOSIS AND ANY BLEEDING WHICH INCLUDED MAJOR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247124 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention