BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 16018715 · Received December 20, 2022

    Report

    Report Number
    2124215-2022-51847
    Event Type
    Death
    Date Received
    December 20, 2022
    Date of Event
    March 7, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    UDI-DI
    08714729876601
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: (B)(6). AGE AT TIME OF EVENT: PATIENT WAS 68 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN ETIOLOGY. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH THREE ELUVIA DRUG ELUTING STENTS AS A PART OF A CLINICAL STUDY. THE TARGET LESION WAS LOCATED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA, DISTAL SFA AND RIGHT PROXIMAL POPLITEAL ARTERY. THE TARGET LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 5.1 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.6 MM. THE TARGET LESION WAS 90 PERCENT STENOSED AND 300 MM IN LENGTH, AND WAS CLASSIFIED AS TASC II C LESION. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF THREE ELUVIA DRUG ELUTING STENTS OF 6.0 MM X 120 MM, 6 MM X 100 MM, AND 6 MM X 80 MM. FOLLOWING STENT PLACEMENT, POST DILATION OF THE TARGET LESION WAS PERFORMED WITH 5 MM X 200 MM AND 5 MM X 80 MM MUSTANG PTA BALLOON. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE ZERO PERCENT, AND THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED WITH ASPIRIN. ON (B)(6) 2022, WHILE ATTEMPTING TO SCHEDULE A 6-MONTH FOLLOW-UP APPOINTMENT, THE STUDY SITE WAS INFORMED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT HAD EXPIRED AT SOME POINT FOLLOWING (B)(6) 2021. THE EXACT DATE OF DEATH WAS UNKNOWN. NO INFORMATION WAS PROVIDED REGARDING THE PATIENT'S CAUSE OF DEATH, THE RELATIONSHIP TO COVID-19, OR THE RELATIONSHIP TO THE ELUVIA STENTS AND THE INDEX PROCEDURE. IT WAS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142458 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24657 0027040255 08714729876601

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death