BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5778097 · Received July 8, 2016

    Report

    Report Number
    9612164-2016-00660
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    July 7, 2015
    Report Date
    June 11, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE ARTICLE WAS AVAILABLE ONLINE JOURNAL ARTICLE TITLE: COMPARISON OF RESOLUTE ZOTAROLIMUS-ELUTING STENTS VERSUS EVEROLIMUS-ELUTING STENTS IN PATIENTS WITH METABOLIC SYNDROME AND ACUTE MYOCARDIAL INFARCTION PROPENSITY SCORE-MATCHED ANALYSIS INTERNATIONAL JOURNAL OF CARDIOLOGY 199 (2015) 53¿62 JOURNAL HOMEPAGE: (B)(6) PUBLISHED BY (B)(6).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE AIM OF THIS STUDY WAS TO COMPARE CLINICAL OUTCOMES OF EVEROLIMUS-ELUTING STENT (EES) AND RESOLUTE-ZOTAROLIMUS-ELUTING STENT (R-ZES) IN AMI PATIENTS WITH METABOLIC SYNDROME (METS), IN TERMS OF STENT-RELATED AND PATIENT-RELATED OUTCOMES. THE (B)(6) IS THE LARGESTMULTICENTER NATIONWIDE REGISTRY, INCLUDING 51 HOSPITALS IN (B)(6), DESIGNED TO EVALUATE CLINICAL OUTCOMES OF AMI PATIENTS THE PATIENT FLOW IS AMONG 38,108 PATIENTS ENROLLED IN THE (B)(6) BETWEEN NOVEMBER 2005 AND MARCH 2012,WE SELECTED A TOTAL OF 3942 PATIENTS WITH AMI, WHO UNDERWENT SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH EES (XIENCE/PROMUS, ABBOTT VASCULAR/BOSTON SCIENTIFIC) OR R-ZES (RESOLUTE ,MEDTRONIC CARDIOVASCULAR) AND COULD BE IDENTIFIED FOR THE PRESENCE OF METS. AFTER THEN, THEY WERE GROUPED ACCORDING TO THE PRESENCE OF METS AND STENT TYPE. OF 3942 PATIENTS, 1837 PATIENTS WERE METS AND TREATED WITH EES (N = 1582) OR R-ZES (N = 255), WHEREAS 2105 PATIENTS WERE NON-METS AND TREATED WITH EES (N = 1818) OR R-ZES (N= 287). IT WAS REPORTED THAT SOME STUDY PARTICIPANTS EXPERIENCED REOCCURRING MI, REVASCULARIZATION INCLUDING TARGET LESION REVASCULARIZATION, TARGET VESSEL REVASCULARIZATION, CAGB AND STENT THROMBOSIS. DEATH WAS ALSO AN OUTCOME FOR SOME PATIENTS. CONCLUSION: THIS STUDY SHOWED THAT IN METS PATIENTS WITH AMI, BOTH EES AND R-ZES HAD COMPARABLE CLINICAL OUTCOMES, WITH LOW STENT-RELATED OUTCOMES. HOWEVER, PATIENT-ORIENTED COMPOSITE EVENTS WERE RELATIVELY HIGH IN THEM, SUGGESTING THAT MORE AGGRESSIVE TREATMENTS BASED ON PATIENT CHARACTERISTICS AS WELL AS MORE EFFORTS TO MINIMIZE SYMPTOMTO- DOOR TIME ARE REQUIRED FOR IMPROVING THE CLINICAL OUTCOME OF THEM. THE AUTHORS OF THIS MANUSCRIPT HAVE CERTIFIED THAT THEY COMPLY WITH THE PRINCIPLES OF ETHICAL PUBLISHING IN THE INTERNATIONAL JOURNAL OF CARDIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432939 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R