BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 11973410 · Received June 10, 2021

    Report

    Report Number
    9612164-2021-02248
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    February 10, 2020
    Report Date
    June 10, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: TREATING VERY LONG CORONARY ARTERY LESIONS IN THE CONTEMPORARY DRUG ELUTING-STENT ERA: SINGLE LONG 48 MM STENT VERSUS TWO OVERLAPPING STENTS SHOWED COMPARABLE CLINICAL OUTCOMES AUTHORS: HUI WEN SIM, ELIZABETH H. THONG, POAY HUAN LOH, CHI-HANG LEE, MARK Y. CHAN, ADRIAN F. LOW, EDGAR L. TAY, KOO HUI CHAN, HUAY CHEEM TAN, JOSHUA P. LOH JOURNAL: CARDIOVASCULAR REVASCULARIZATION MEDICINE YEAR:2020 REFERENCE: DOI.ORG/10.1016/J.CARREV.2020.02.005 PATIENT DEATHS WERE ALSO INCLUDED IN THE RESULTS OF THE JOURNAL ARTICLE, HOWEVER NO CAUSAL LINK SUGGESTING THAT THE MEDTRONIC DEVICE USED IN THE PATIENT COHORT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATHS WAS PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE TITLED - TREATING VERY LONG CORONARY ARTERY LESIONS IN THE CONTEMPORARY DRUG-ELUTING-STENT ERA: SINGLE LONG 48 MM STENT VERSUS TWO OVERLAPPING STENTS SHOWED COMPARABLE CLINICAL OUTCOMES - WAS SUBMITTED FOR REVIEW. THIS STUDY AIMED TO COMPARE THE TWO-YEAR CLINICAL OUTCOMES BETWEEN 48 MM SINGLE LONG CONTEMPORARY DRUG ELUTING STENTS (DES) VERSUS TWO OVERLAPPING CONTEMPORARY DES IN THE TREATMENT OF VERY-LONG CORONARY ARTERY DISEASE (CAD). THE PRIMARY ENDPOINT WAS TARGET LESION FAILURE (TLF) AT TWO YEARS, DEFINED AS A COMPOSITE OF CARDIAC MORTALITY, TARGET VESSEL MYOCARDIAL INFARCTION (MI), AND TARGET LESION REVASCULARIZATION (TLR). ADDITIONAL ENDPOINTS INCLUDED MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE); DEFINED AS A COMPOSITE OF ALL-CAUSE MORTALITY, MI, OR ISCHEMIA DRIVEN TLR, DEFINITE AND PROBABLE STENT THROMBOSIS (ST), AND THE INDIVIDUAL COMPONENTS OF TLF AND MACE. DEATHS NOT ATTRIBUTABLE TO ANOTHER CAUSE WERE CONSIDERED CARDIAC DEATHS. A TOTAL OF 117 PATIENTS WERE TREATED WITH SINGLE LONG 48 MM SINGLE LONG DES (SL-DES) VERSUS 101 PATIENTS TREATED WITH TWO OVERLAPPING CONTEMPORARY DES (OL-DES). ALL THE PATIENTS IN SL-DES GROUP RECEIVED A NON-MEDTRONIC (MDT) STENT, WHILE PATIENTS ASSIGNED TO THE OL-DES GROUP RECEIVED EITHER MEDTRONIC RESOLUTE INTEGRITY DES OR OTHER NON-MDT DES. EVENTS OF TLF, MACE AND THEIR INDIVIDUAL COMPONENTS WAS SEEN IN BOTH THE SL-DES AND OL-DES STUDY GROUPS AT TWO YEARS. THERE WERE TWO CASES OF SUDDEN CARDIAC DEATH THAT CATEGORIZED AS PROBABLE ST (ONE IN EACH TREATMENT GROUP) WITHOUT ANGIOGRAPHIC CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869440 RESOLUTE INTEGRITY RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention