BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6150990 · Received December 7, 2016

    Report

    Report Number
    9612164-2016-01231
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 2, 2014
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW :THE IMAGES REPRESENT OCT IMAGES OF POST-INTERVENTION AT 1 ,2 AND 3 MONTHS FOLLOW UP POST RESOLUTE INTEGRITY STENT IMPLANTATION. THE IMAGES SHOW LOW SIGNAL INTENSITY. DATE OF EVENT - DATE OF PUBLICATION. HEART VESSELS (2016) 31: 206-211 ''NEOINTIMAL COVERAGE OF ZOTAROLIMUS-ELUTING STENT AT 1, 2, AND 3 MONTHS¿ FOLLOW-UP: AN OPTICAL COHERENCE TOMOGRAPHY STUDY'' DOI 10.1007/S00380-014-0598-0.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM (B)(6) 2012 TO (B)(6) 2014, A TOTAL OF 20 PATIENTS WHO HAD MULTI-VESSEL CORONARY LESION WERE RANDOMIZED TO OBSERVE BY OPTICAL COHERENCE TOMOGRAPHY (OCT) NEOINTIMAL COVERAGE AFTER RESOLUTE INTEGRITY IMPLANTATION. CORONARY ANGIOPLASTY WAS PERFORMED ACCORDING TO STANDARD TECHNIQUES. BEFORE THE 1ST INTERVENTION, ALL PATIENTS WITH ACUTE CORONARY SYNDROME RECEIVED ASPIRIN AND CLOPIDOGREL, AND PATIENTS WITH STABLE ANGINA PECTORIS STARTED RECEIVING DAPT. TARGET LESIONS WERE LOCATED IN THE RIGHT CORONARY, LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX ARTERIES. AFTER THE INTERVENTION, ALL PATIENTS CONTINUED TO RECEIVE DAPT DURING THE ENTIRE STUDY PERIOD. ALL PATIENTS HAD MULTI-VESSEL LESIONS; THEREFORE, STAGED PCI WAS PERFORMED AT MONTHS 1¿3 AFTER THE INDEX PCI WITH R-ZES. TIME-COURSE OCT WAS CONDUCTED CONCURRENTLY WITH STAGED PCI AT MONTHS 1, 2, AND 3 AFTER R-ZES IMPLANTATION TO DETERMINE THE PERCENTAGE OF STENT STRUT COVERAGE. (B)(6) PROCEDURES REVEALED NO SERIOUS COMPLICATIONS DURING OR AFTER THE IMPLANTATION OF R-ZES. OCT IMAGES CONFIRMED MALAPPOSED STENT STRUTS. THROMBUS WAS DETECTED IN 2 STENTS. NO CLINICAL EVENTS WERE OBSERVED IN THE PATIENTS DURING THE STUDY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802090 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR