BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY XD

    MDR report key: 15998960 · Received December 16, 2022

    Report

    Report Number
    2124215-2022-52938
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 28, 2022
    Report Date
    December 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729980889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH 5113583 THAT STENT FRACTURE AND MIGRATION OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN AND UPON EVALUATION WAS NOTED TO BE A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WITH ANGIOGRAM AND POSSIBLE STENT PLACEMENT. CARDIAC CATHETERIZATION WAS PERFORMED USING A 2.75 X 16 SYNERGY XD DRUG-ELUTING STENT. HOWEVER, DURING WITHDRAWAL, MULTIPLE STRANDS OF STENT MATERIAL CAME FREE AND REMAINED IN THE PATIENT, POSSIBLY IN THE AORTA. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE FRAYING OBJECT WITH A SNARE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152257 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION H7493941816270 0028266143 08714729980889

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| O