BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY XD DRUG ELUTING STENT

    MDR report key: 17408398 · Received July 26, 2023

    Report

    Report Number
    MW5120195
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2023 PATIENT TO OUTLYING EMERGENCY DEPARTMENT FOR CHEST PRESSURE AND INCREASING SOB. TRANSFER TO OUR FACILITY FOR DX (DIAGNOSIS) CARDIAC CATH. FILMS REVEAL MULTI VESSEL DISEASE, MULTI-DISCIPLINARY DECISION TO PROCEED WITH PCI OF L MAIN/PROX LAD (PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY) AND L DOMINANT PROX CIRC (PROXIMAL CIRCUMFLEX) (B)(6) 2023. 90% PROX CIRC (PROXIMAL CIRCUMFLEX) TREATED WITH 3.5X20 NC EUPHORA BALLOON; 4X38 SYNERGY XD STENT PLACED AND POST DILATED WITH 4.5X12 NC EUPHORA. FINAL FILMS REVEAL GOOD RESULT WITH TIMI III FLOW. PATIENT CONTINUED TO DO WELL AND WAS DISCHARGED (B)(6) 2023 WITH MEDS INCLUDING ASA 81MG AND PLAVIX 75MG. PATIENT REPORTS BEING COMPLIANT WITH MEDS. (B)(6) 2023 PATIENT RETURNS TO OUTLYING ED WITH INCREASING SOB, NO CHEST DISCOMFORT. OVER THE NEXT WEEK TREATED FOR RESPIRATORY DISTRESS, ACUTE ON CHRONIC CHF, AKI, AND NONSTEMI. (B)(6) 2023 PATIENT'S RESPIRATORY AND RENAL FUNCTION STABILIZED AND TRANSFERRED TO OUR FACILITY FOR REPEAT CATH. FILMS REVEAL SUBACUTE THROMBOSIS OF PREVIOUSLY PLACED STENT TO PROX CIRC (PROXIMAL CIRCUMFLEX). TREATED WITH 3X15 AND 4.5X15 NC EUPHORA AND MULTIPLE PASSES WITH PENUMBRA ASPIRATION CATHETER. FINAL FILMS REVEAL TMI III FLOW. PATIENT CONTINUES TO DO WELL AND IS DISCHARGED (B)(6) 2023 ON MEDS INCLUDING ASA 81MG AND PLAVIX 75MG. REFERENCE REPORT: #MW5120196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773163 SYNERGY XD DRUG ELUTING STENT CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. HC278C1874

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention ASPIRIN 81MG.| PLAVIX 75MG.