BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY XD

    MDR report key: 20034743 · Received August 22, 2024

    Report

    Report Number
    2124215-2024-50283
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: USED FIRST DAY OF THE MONTH OF THE POSTER SESSION SINCE THE EVENT DATE WAS NOT REPORTED. CVIT 2024: THE 32ND ANNUAL MEETING OF THE JAPAN SOCIETY OF CARDIOVASCULAR INTERVENTIONAL THERAPY, MEDICAL POSTER SESSION 17, ACS 3, 2024-7-25, 1400-1500; SHNICHI OKINO - CHAIR, TAKAO MAKINO - CHAIR; YUTO WATANABE, ET. AL.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN ANNUAL MEETING THAT PATIENT COMPLICATIONS OCCURRED. THE PATIENT PRESENTED WITH CONTINUOUS CHEST PAIN AND LOSS OF CONSCIOUSNESS AND WAS DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION. AFTER ASPIRATION OF THE THROMBUS, A 4.00MMX24MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS IMPLANTED. ONE HOUR AFTER ADMISSION TO THE CARDIAC CARE UNIT, VENTRICULAR FIBRILLATION OCCURRED. AFTER SUCCESSFUL RESUSCITATION, AN ANGIOGRAM REVEALED THE STENT WAS FILLED WITH THROMBUS RESULTING IN ACUTE CORONARY OCCLUSION. THE PHYSICIAN ASPIRATED THE THROMBUS AGAIN AND MALPOSED STRUTS WAS NOT OBSERVED BY INTRAVASCULAR ULTRASOUND (IVUS). A 4.00MM X 20MM NON-BOSTON SCIENTIFIC (NON-BSC) PERFUSION BALLOON WAS DILATED AGAIN AND AGAIN, BUT THROMBUS FORMED IN THE DES. FINALLY, A COVERED 3.0MM X 20MM NON BSC STENT WAS IMPLANTED IN THE DES SITE. CORONARY ANGIOGRAPHY WAS PERFORMED ON THE SECOND HOSPITAL DAY AND A SMALL AMOUNT OF THROMBUS REMAINED, BUT STENT APPOSITION WAS APPROPRIATE. ON THE 10TH HOSPITAL DAY, NO THROMBUS WAS FOUND IN THE STENT AND THE PATIENT WAS DISCHARGED ON THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18831 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R