BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 16618988 · Received March 27, 2023

    Report

    Report Number
    2124215-2023-13855
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    May 24, 2022
    Report Date
    March 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED USING THE DATE THE JOURNAL ARTICLE WAS RECEIVED FOR PUBLICATION. SAITO, S., KOGAME, N., UTSUNOMIYA, M. ET AL. DELAYED RUPTURE OF SUPERFICIAL FEMORAL ARTERIAL ANEURYSM AT THE FLUOROPOLYMER-BASED PACLITAXEL-ELUTING STENT IMPLANTED SITE. CARDIOVASC INTERV AND THER 38, 132-133 (2023). HTTPS://DOI.ORG/10.1007/S12928-022-00882-Y.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT AN ANEURYSM FORMED AND THEN LATER RUPTURED POST INDEX PROCEDURE. THE CHRONIC TOTAL OCCLUSION (CTO) OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF A PATIENT WITH RUTHERFORD CLASS-4 SYMPTOM WAS SUCCESSFULLY TREATED WITH SUBINTIMAL WIRE TRACKING AND SUBSEQUENT IMPLANTATION OF A 7X120MM ELUVIA DRUG-ELUTING VASCULAR STENT. BECAUSE OF IODINE-ANAPHYLAXIS HISTORY, THIS PROCEDURE WAS GUIDED BY CO2 ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) FOR BAIL OUT OF NO-FLOW PHENOMENON AFTER FIRST DRUG-ELUTING STENT (DES) IMPLANTATION. THE POST-HOC ANALYSIS OF CO2 ANGIOGRAPHY REVEALED A SMALL ANEURYSM IN THE PROXIMAL SFA STENTED SITE, BUT IT COULD NOT BE SPECIFIED AT THIS TIME. SIX MONTHS LATER, THE PATIENT PRESENTED WITH SUDDEN RIGHT INGUINAL PAIN AND HEMORRHAGIC SHOCK WITH A HEMOGLOBIN OF 5.1 G/DL. DUPLEX ULTRASOUND AND COMPUTED TOMOGRAPHY SUGGESTED AN ANEURYSM RUPTURE AROUND THE STENT WITH A LARGE HEMATOMA EXTENDING TO THE RETROPERITONEUM. ENDOVASCULAR TREATMENT WAS PERFORMED TO MINIMIZE ANY DELAY UNTIL HEMOSTASIS WAS ACHIEVED. CO2 ANGIOGRAPHY AND IVUS CONFIRMED BLEEDING OUTSIDE THE STENT. HEMOSTASIS WAS ACHIEVED BY IMPLANTING A 7X100MM NON-BOSTON SCIENTIFIC STENT-GRAFT INSIDE THE INITIAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493452 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention