BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7984926 · Received October 19, 2018

    Report

    Report Number
    9612164-2018-02836
    Event Type
    Death
    Date Received
    October 19, 2018
    Date of Event
    April 25, 2018
    Report Date
    October 19, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE 66, GENDER MALE, EVENT DATE: DATE OF JOURNAL ACCEPTANCE. JOURNAL ARTICLE: ENDOTHELIAL DYSFUNCTION AS PREDICTOR OF ANGINA RECURRENCE AFTER SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION USING SECOND GENERATION DRUG ELUTING STENTS EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY 2018, VOL. 25(13) 1360¿1370 ! THE EUROPEAN SOCIETY OF CARDIOLOGY 2018 ARTICLE REUSE GUIDELINES: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/2047487318777435 JOURNALS.SAGEPUB.COM/HOME/EJPC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT BACKGROUND: THE ROLE OF ENDOTHELIAL DYSFUNCTION IN PREDICTING ANGINA RECURRENCE AFTER PERCUTANEOUS CORONARY INTERVENTION IS UNKNOWN. DESIGN: WE ASSESSED THE ROLE OF PERIPHERAL ENDOTHELIAL DYSFUNCTION MEASURED BY REACTIVE-HYPERAEMIA PERIPHERAL-ARTERY TONOMETRY (RH-PAT) IN PREDICTING RECURRENCE OF ANGINA AFTER PERCUTANEOUS CORONARY INTERVENTION. METHODS: WE ENROLLED CONSECUTIVE PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION WITH SECOND-GENERATION DRUG-ELUTING STENTS. RH-PAT WAS MEASURED AT DISCHARGE. THE ENDPOINT WAS REPEATED CORONARY ANGIOGRAPHY FOR ANGINA RECURRENCE AND/OR EVIDENCE OF MYOCARDIAL ISCHAEMIA AT FOLLOW-UP. PATIENTS WITH IN-STENT RESTENOSIS AND/OR SIGNIFICANT DE NOVO STENOSIS WERE DEFINED AS HAVING ANGINA WITH OBSTRUCTED CORONARY ARTERIES (AOCA); ALL OTHER PATIENTS AS HAVING ANGINA WITH NON-OBSTRUCTED CORONARY ARTERIES (ANOCA). RESULTS: AMONG 100 PATIENTS (MEAN AGE 66.7 10.4 YEARS, 80 (80.0%) MALE, MEDIAN FOLLOW-UP 16 (3¿20) MONTHS), AOCA OCCURRED IN 14 PATIENTS (14%), ANOCA IN NINE PATIENTS (9%). REPEATED CORONARY ANGIOGRAPHY OCCURRED MORE FREQUENTLY AMONG PATIENTS IN THE LOWER RH-PAT INDEX TERTILE COMPARED WITH MIDDLE AND UPPER TERTILES (14 (41.2%) VS. 6 (18.2%) VS. 3 (9.1%), P¼0.006, RESPECTIVELY). ANOCA WAS MORE FREQUENT IN THE LOWER RH-PAT INDEX TERTILE COMPARED WITH MIDDLE AND UPPER TERTILES. IN THE MULTIVARIATE REGRESSION ANALYSIS, THE RH-PAT INDEX ONLY PREDICTED ANGINA RECURRENCE. THE RECEIVER OPERATING CHARACTERISTIC CURVE OF THE RH-PAT INDEX TO PREDICT THE ANGINA RECURRENCE DEMONSTRATED AN AREA UNDER THE CURVE OF 0.79 (95% CONFIDENCE INTERVAL: 0.69¿0.89; P0.001), WITH A CUT-OFF VALUE OF 1.705, HAVING SENSITIVITY 74% AND SPECIFICITY 70%. CONCLUSIONS: NON-INVASIVE ASSESSMENT OF PERIPHERAL ENDOTHELIAL DYSFUNCTION USING RH-PAT MIGHT HELP IN THE PREDICTION OF RECURRENT AN GINA AFTER PERCUTANEOUS CORONARY INTERVENTION, THUS IDENTIFYING PATIENTS WHO MAY NEED MORE INTENSE PHARMACOLOGICAL TREATMENT AND RISK FACTOR CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826397 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death