BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7968471 · Received October 16, 2018

    Report

    Report Number
    9612164-2018-02750
    Event Type
    Death
    Date Received
    October 16, 2018
    Date of Event
    June 21, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: DATE OF PUBLICATION JOURNAL ARTICLE: EVOLUTION OF THE SYNERGY BIORESORBABLE POLYMER METALLIC CORONARY STENT FUTURE MEDICINE SATYA S SHREENIVAS1 <(>&<)> DEAN J KEREIAKES*,(B)(6) HOSPITAL HEART <(>&<)> VASCULAR CENTER/THE CARL <(>&<)> EDYTH LINDNER CENTER FOR RESEARCH <(>&<)> EDUCATION AT (B)(6) HOSPITAL, (B)(6), USA 10.2217/FCA-2018-0040 C 2018 FUTURE MEDICINE LTD FUTURE CARDIOL. (2018) 14(4), 307¿317 ISSN 1479-6678 307 REVIEW SHREENIVAS <(>&<)> KEREIAKES . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL THAT RESOLUTE INTEGRITY AND RESOLUTE ONYX RX DRUG ELUTING STENTS WERE USED AS PART OF THE (B)(6) STUDY. REPORTED ADVERSE EVENTS INCLUDED MI, STENT THROMBOSIS, CVA, DEATH AND TVR CARDIOVASCULAR DISEASE CAUSES ONE OUT OF EVERY THREE DEATHS IN THE USA WITH CORONARY HEART DISEASE AS THE LEADING ETIOLOGY (45.1%). MEDICAL THERAPY AND PERCUTANEOUS CORONARY INTERVENTION (PCI) ARE THE MAINSTAYS OF TREATMENT FOR CORONARY HEART DISEASE. EVOLUTION IN PCI WITH PROGRESSION FROM BALLOON ANGIOPLASTY TO BARE METAL STENTS (BMS), AND THEN TO FIRST AND SECOND GENERATION DRUG ELUTING STENTS (1GDES, 2GDES) HAS BEEN ASSOCIATED WITH IMPROVEMENT IN MAJOR ADVERSE CARDIOVASCULAR EVENTS, DRIVEN LARGELY BY IMPROVEMENT IN EARLY CORONARY OCCLUSION, THROMBOSIS AND RESTENOSIS. ALTHOUGH ITERATIONS IN METALLIC DES, INCLUDING NOVEL METAL ALLOY COMPOSITION, REDUCED STRUT THICKNESS, AS WELL AS IMPROVED POLYMER BIOCOMPATIBILITY AND BIORESORPTION HAVE IMPROVED 1-YEAR OUTCOMES, BEYOND 1-YEAR FOLLOWING STENT DEPLOYMENT THERE APPEARS TO BE A 2¿4% ANNUAL INCIDENCE OF STENT RELATED EVENTS REGARDLESS OF DEVICE. INDEED, A RECENT PATIENT LEVEL META-ANALYSIS OF 17 RANDOMIZED, CONTROLLED CLINICAL TRIALS OF BMS, 1 AND 2GDES INCLUDING 18 ,250 PATIENTS, DEMONSTRATED A 2.1¿2.9% ANNUAL INCIDENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS; COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION (MI), ISCHEMIA-DRIVEN TARGET LESION REVASCULARIZATION (ID-TLR) BETWEEN 1- AND 5-YEAR FOLLOW-UP REGARDLESS OF DEVICE. SIMILARLY, 3¿5-YEAR FOLLOW-UP FROM TRIALS OF 2GDES DEMONSTRATED A 2¿4% ANNUAL INCIDENCE OF DEVICE RELATED OUTCOMES (TARGET LESION FAILURE [TLF]); A COMPOSITE ENDPOINT INCLUDING CARDIAC RELATED DEATH, TARGET VESSEL RELATED MI AND CLINICALLY INDICATED/ID-TLR BEYOND 1-YEAR ACROSS A BROAD SPECTRUM OF PATIENTS. THE PATHOPHYSIOLOGIC MECHANISM(S) UNDERLYING THESE VERY LATE EVENTS MAY BE THE COMMON PRESENCE OF A METALLIC IMPLANT THATMECHANICALLY DISTORTS AND CONSTRAINS THE VESSEL, PREVENTING NORMAL VASOMOTION, AUTOREGULATION AND ADAPTIVE REMODELING AND/OR THE PRESENCE OF A PERMANENT POLYMER WHICH MAY BE ASSOCIATED WITH CHRONIC INFLAMMATION, DELAYED HEALING/ INCOMPLETE ENDOTHELIALIZATION OR NEOATHEROSCLEROSIS. IN ATTEMPT TO REDUCE POLYMER RELATED INFLAMMATION AND NEOATHEROSCLEROSIS AS WELL AS TO ENHANCE STENT HEALING, BIORESORBABLE POLYMER METALLIC DES SUCH AS SYNERGY (BOSTON SCIENTIFIC CORP (B)(4)) HAVE BEEN DEVELOPED. THE SYNERGY STENT INCORPORATES MULTIPLE DESIGN ELEMENTS SPECIFICALLY AIMED TOWARD RAPID AND COMPLETE STENT HEALING AND REDUCED THROMBOSIS INCLUDING THIN, PLATINUM-CHROMIUM (PTCR) METAL ALLOY STRUTS AND AN ULTRATHIN, BIOABSORBABLE POLY-DL-LACTIDE-CO-GLYCOLIDE (PLGA) POLYMER LIMITED TO THE ABLUMINAL STRUT SURFACE WHICH RESORBS OVER 3¿4 MONTHS FOLLOWING ELUTION OF EVEROLIMUS (EES). IN ADDITION TO THE AFOREMENTIONED RANDOMIZED TRIALS, THE (B)(6) EXAMINED THE PERFORMANCE OF SYNERGY IN A REAL-WORLD POPULATION BY COMPARING IT AGAINST ALL OTHER NEW GENERATION STENTS THAT HAD >1000 IMPLANTS DURING THE YEARS 2013¿2015 [40]. THERE WERE 7886 SYNERGY IMPLANTS AND COMPARATIVE STENTS INCLUDED BIOMATRIX (N = 1953), ORSIRO (N = 4946), PROMUS ELEMENT PLUS (N = 2543), PROMUS PREMIER (N = 20,414), XIENCE XPEDITION (N = 7971), RESOLUTE/RESOLUTE INTEGRITY (N = 19,021), ULTIMASTER (N = 1156), RESOLUTE ONYX (N = 6425). THE PATIENTS IMPLANTED WITH SYNERGY WERE MORE LIKELY TO BE DIABETIC (23.1 VS 21.9%; P <(><<)> 0.01), AND TO HAVE HAD A PRIORMI (30 VS 27.8%; P <(><<)> 0.01), TRIPLE VESSEL DISEASE (17.4VS 16.6%; P <(><<)> 0.01), BIFURCATION LESIONS (14.1 VS 12.9 %; P <(><<)> 0.01), SMALLER VESSELS (STENT DIAMETER: 2.95 ± 0.52 VS 3.00 ± 0.51; P <(><<)> 0.01) AND LONGER LESIONS (22.32 ± 8.72 VS 20.32 ± 7.84; P <(><<)> 0.01). DESPITE THESE NUMEROUS HIGHER RISK CLINICAL AND ANGIOGRAPHIC FEATURES, RATES OF RESTENOSIS WERE LOW WITH BOTH SYNERGY AND THE NOVEL STENT PLATFORMS (1.1 VS 1.0% RESPECTIVELY, ADJUSTED HAZARD RATIO: 1.24; 95% CI: 0.88¿1.75; P = 0.21). SIMILARLY, RATES OF ST WERE LOW WITH BOTH SYNERGY AND THE NOVEL STENTS (0.4 VS 0.5%; ADJUSTED HAZARD RATIO: 0.97; 95% CI: 0.63¿1.50; P = 0.17). AT LAST, RATES OF ALL-CAUSE DEATH AND MI WERE SIMILAR BETWEEN THE TWO GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808959 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death