BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY¿

    MDR report key: 7587876 · Received June 11, 2018

    Report

    Report Number
    2134265-2018-05126
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Report Date
    May 15, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FUJIMOTO, YOSHIHIE, ET. AL., 'DELAMINATION OF NOVEL ULTRATHIN BIOABSORBABLE ABLUMINAL POLYMER OF PLATINUM CHROMIUM EVEROLIMUS-ELUTING STENT', CARDIOASC INTERV AND THER 2018 33:97-98, HTTPS://DOI.ORG/10.1007/S12928-016-0442-9. DEVICE IS A COMBINATION PRODUCT. (B)(6). (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE THAT POLYMER DELAMINATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). AFTER PREDILATATION, DELIVERY OF A 24MM SYNERGY STENT IN THE MID-LAD WAS ATTEMPTED. HOWEVER, IT WOULD NOT ADVANCE TO THE TARGET LESION IN THE MID-LAD EVEN WITH THE A NON-BSC GUIDE EXTENSION CATHETER. ROTATIONAL ATHERECTOMY WAS PERFORMED. A DURABLE POLYMER EVEROLIMUS-ELUTING STENT WAS THEN DEPLOYED. THE FINAL ANGIOGRAM SHOWED A GOOD RESULT. SCANNING ELECTRON MICROSCOPY DEMONSTRATED DAMAGE TO THE BIOABSORBABLE POLYMER OF THE SYNERGY STENT; MOST OF THE DAMAGE WAS DELAMINATION OF ABLUMINAL POLYMER. IT WAS CONCLUDED THAT DELAMINATION OF ABLUMINAL BIOABSORBABLE POLYMER MAY OCCUR MORE EASILY AND SEVERELY WHEN IT IS DELIVERED THROUGH A CALCIFIED CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430024 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK776

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR