BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 9284160 · Received November 6, 2019

    Report

    Report Number
    9612164-2019-04661
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    May 11, 2019
    Report Date
    November 6, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL AND ANGIOGRAPHIC OUTCOMES OF BIOABSORBABLE VS. PERMANENT POLYMER DRUG-ELUTING STENTS IN SWEDEN: A REPORT FROM THE SWEDISH CORONARY ANGIOPLASTY REGISTRY (SCAAR) SERGIO BUCCHERI, STEFAN JAMES, DANIEL LINDHOLM, OLE FROBERT, GORAN K. OLIVECRONA, JONAS PERSSON, KRISTIINA HAMBRAEUS, NILS WITT, DAVID ERLINGE, OSKAR ANGERAS, BO LAGERQVIST AND GIOVANNA SARNO EUROPEAN HEART JOURNAL (2019) 40, 2607-2615 DOI:10.1093/EURHEART/EHZ244. AGE AVERAGE AGE. SEX: MAJORITY GENDER. DATE OF EVENT: DATE OF PUBLICATION DEATH WAS REPORTED AS A CLINICAL OUTCOME OF THIS STUDY, HOWEVER THERE IS NO INFORMATION TO SUGGEST THE DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS STUDY INVESTIGATED THE COMPARATIVE OUTCOMES OF BIOABSORBABLE POLYMER DES (BP-DES) AND PERMANENT POLYMER DES (PP-DES) IMPLANTED ACROSS SWEDISH CARDIAC CATHETERIZATION LABORATORIES FROM OCTOBER 2011 TO JUNE 2016. RESOLUTE INTEGRITY AND RESOLUTE ONYX DEVICES ALONG WITH NON-MEDTRONIC DRUG ELUTING STENTS IMPLANTED AMONG THE 79,106 PP-DES IMPLANTED IN 47 ,455 INDIVIDUAL PATIENTS. LESIONS TREATED INCLUDED THE LEFT MAIN, RIGHT CORONARY, LEFT ANTERIOR DESCENDING, LEFT CIRCUMFLEX ARTERIES, ARTERIAL GRAFT AND VEIN GRAFT WERE TREATED WITH CHRONIC TOTAL OCCLUSION IN 2547 PATIENTS, BIFURCATION IN 8486 PATIENTS. 2,149 PATIENTS EXHIBITED RESTENOTIC LESIONS. ROTATIONAL ATHERECTOMY WAS USED IN 404 PATIENTS, DIRECT STENTING IN 12 ,482 PATIENTS, AND POST-DILATION PERFORMED IN 18,087 PATIENTS. COMPLETE REVASCULARIZATION WAS CARRIED OUT IN 31,843 CASES. FOLLOW-UP ANALYSIS CARRIED OUT ACROSS BOTH PP-DES AND BP-DES GROUPS FOR UP TO 2 YEARS REPORTED RESTENOSIS, STENT THROMBOSIS, MYOCARDIAL INFARCTION AND ALL CAUSE MORTALITY. THE STUDY WAS UNABLE TO CLASSIFY DIFFERENT CAUSES OF DEATH .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082590 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R