BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 12340817 · Received August 19, 2021

    Report

    Report Number
    9612164-2021-03195
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    July 17, 2020
    Report Date
    August 19, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: INDEPENDENT FACTORS FOR IN-HOSPITAL DEATH FOLLOWING DRUG-ELUTING STENT THROMBOSIS FROM THE JAPANESE ADVERSE EVENT REPORT SYSTEM AUTHORS: YOSHIAKI MITSUTAKE, AKIHIDE KONISHI, NOBUHIRO HANDA, MAMI HO, HARUKI SHIRATO, TAKUYA ITO, KAZUHISA KOIKE, SHUICHI MOCHIZUKI, KENSUKE ISHII YEAR: 2020 REFERENCE: DOI:10.1253/CIRCJ.CJ-20-0133 PATIENT DEATHS WERE ALSO INCLUDED IN THE RESULTS OF THE JOURNAL ARTICLE, HOWEVER NO CAUSAL LINK SUGGESTING THAT THE MEDTRONIC DEVICES 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 - INDEPENDENT FACTORS FOR IN-HOSPITAL DEATH FOLLOWING DRUG-ELUTING STENT THROMBOSIS FROM THE JAPANESE ADVERSE EVENT REPORT SYSTEM - WAS SUBMITTED FOR REVIEW. THIS STUDY AIMED TO SURVEY THE CHARACTERISTICS OF STENT THROMBOSIS (ST) CASES AND EVALUATE INDEPENDENT FACTORS FOR IN-HOSPITAL DEATH SUBSEQUENT TO DRUG-ELUTING STENT (DES) ST, USING DATA FROM THE JAPANESE ADVERSE EVENT REPORTING SYSTEM. DEFINITE ST WAS CATEGORIZED ACCORDING TO THE TIME OF OCCURRENCE: EARLY ST (EST) WAS DEFINED AS WITHIN 30 DAYS AFTER STENT IMPLANTATION, LATE ST (LST) AS 31¿365 DAYS AFTER STENT DEPLOYMENT, AND VERY LATE ST (VLST) AS >365 DAYS AFTER STENT IMPLANTATION. MEDTRONIC'S ENDEAVOR RX DES AND RESOLUTE INTEGRITY DES WERE AMONG THE DES USED IN THE STUDY POPULATION. A TOTAL OF 2,045 PATIENTS WERE IDENTIFIED AS HAVING ANGIOGRAPHIC DEFINITE ST. THERE WERE 1,288 PATIENTS WITH EST, 307 WITH LST, AND 450 WITH VLST. THERE WERE 286 IN-HOSPITAL DEATHS AFTER ST OCCURRENCE. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR >90% OF PATIENTS AS TREATMENT FOR ST. MOST PATIENTS UNDERWENT THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY. OTHER INTERVENTIONAL PROCEDURES INCLUDED INTRA-AORTIC BALLOON PUMPING (IABP), CORONARY ARTERY BYPASS SURGERY (CABG) AND PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). IT WAS EVALUATED THAT LEFT MAIN TRUNK (LMT) DISEASE, CHRONIC HEART FAILURE (CHF), HEMODIALYSIS, PRIOR STROKE, AND AGED OVER 70 YEARS OLD WERE INDEPENDENT FACTORS FOR IN-HOSPITAL DEATH AFTER DES-ST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242384 RESOLUTE INTEGRITY RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention