BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6406121 · Received March 15, 2017

    Report

    Report Number
    9612164-2017-00274
    Event Type
    Injury
    Date Received
    March 15, 2017
    Report Date
    February 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JACC: CARDI O V AS C ULAR I NT E R V E N T IONS 2017 VOL . 1 0, NO. 1 , 2 0 1 7 LABELING STENTS/SCAFFOLDS FOR DIABETES: REAL SCIENCE OR MARKETING STUNT? H T T P : / / D X . D O I . O R G / 1 0 . 1 01 6 / J . J C I N . 2 0 1 6 . 1 1 . 0 2 3 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: AS PART OF THE DEVELOPMENT OF SECOND-GENERATION DES, INTEREST WAS SHOWN IN ADDITIONAL OUTCOME DATA IN DIABETIC PATIENTS, AND SPONSORS SOUGHT A SPECIFIC INDICATION FOR DIABETIC PATIENTS ON LABELING. WORK WAS DONE TO DEVELOP A PERFORMANCE GOAL (PG) TO ADDRESS SAFETY AND EFFECTIVENESS CONCERNS ASSOCIATED WITH DES USE IN DIABETIC PATIENTS. THE PG WAS BASED ON POOLED OUTCOME DATA FROM FIRST-GENERATION DES IN THE DIABETIC POPULATION. SPECIFICALLY, 1-YEAR TARGET-VESSEL-FAILURE (TVF) OUTCOMES FOR DIABETES MELLITUS (DM) PATIENTS IMPLANTED WITH THE RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING STENT (ZES) WERE COMPARED AGAINST A PG DERIVED FROM A META-ANALYSIS THAT INCLUDED 6 TRIALS FROM TWO DIFFERENT NON MEDTRONIC DES MANUFACTURERS, ALONG WITH POOLED DATA FOR THE ENDEAVOR ZES. THE RATE OF TVF¿A COMPOSITE ENDPOINT THAT INCLUDED CARDIAC DEATH, MYOCARDIAL INFARCTION, AND TARGET VESSEL REVASCULARIZATION¿ FOR THE DIABETIC ZES PATIENTS WAS 7.8% (UPPER 95% CONFIDENCE INTERVAL 9.51%).THAT MET THE PG OF 14.5% (P ¼ 0.001), AND RESOLUTE WAS GRANTED THE NEW INDICATION FOR DM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189229 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization