BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 15337129 · Received September 1, 2022

    Report

    Report Number
    2124215-2022-33482
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    June 21, 2022
    Report Date
    October 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT: PATIENT WAS 78 YEARS OLD AT THE TIME OF STUDY ENROLLMENT IN 2019.

    Additional Manufacturer Narrative · 0

    A2. AGE AT TIME OF EVENT: PATIENT WAS 78 YEARS OLD AT THE TIME OF STUDY ENROLLMENT IN 2019. H6: PATIENT CODES: UPDATED FROM ANEURYSM TO PSEUDOANEURYSM. B7: OTHER RELEVANT HISTORY: ADDITIONAL INFORMATION B5: DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    EMINENT CLINICAL STUDY. IT WAS REPORTED THAT THE STENT BROKE AND AN IN STENT ANEURYSM OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS AND WAS 116 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 4.4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.2 MM AND WAS CLASSIFIED AS A TASC II B LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, FOLLOWED BY THE PLACEMENT OF THE 6 MM X 120 MM STUDY STENT. POST DILATATION WAS PERFORMED WITH FINAL RESIDUAL STENOSIS OF 0%. ON (B)(6) 2019, VENOUS BLEEDING AT PUNCTURE SITE OCCURRED. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2022, 917 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH PRESENCE OF ANEURYSM IN THE STENT AFTER A BROKEN STENT. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. SUBJECT UNDERWENT AN INTERVENTIONAL PROCEDURE BY IMPLANTING A STENT GRAFT, AS A TREATMENT FOR THE EVENT. THE EVENT WAS CONSIDERED RESOLVED.

    Description of Event or Problem · 0

    EMINENT CLINICAL STUDY IT WAS REPORTED THAT THE STENT BROKE AND AN IN STENT ANEURYSM OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS AND WAS 116 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 4.4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.2 MM AND WAS CLASSIFIED AS A TASC II B LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, FOLLOWED BY THE PLACEMENT OF THE 6 MM X 120 MM STUDY STENT. POST DILATATION WAS PERFORMED WITH FINAL RESIDUAL STENOSIS OF 0%. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2019, VENOUS BLEEDING AT PUNCTURE SITE OCCURRED. ON (B)(6) 2022, 917 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH PRESENCE OF ANEURYSM IN THE STENT AFTER A BROKEN STENT. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. SUBJECT UNDERWENT AN INTERVENTIONAL PROCEDURE BY IMPLANTATION OF A STENT GRAFT AS A TREATMENT FOR THE EVENT. ON (B)(6)2022, THE EVENT WAS CONSIDERED AS RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6)2021, 731 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED FOR PROTOCOL SCHEDULED 24 MONTHS FOLLOW UP VISIT. ON ARRIVAL, RUTHERFORD CATEGORY WAS 0 (ASYMPTOMATIC). ANKLE BRACHIAL INDEX WAS 0.79. ON THE SAME DAY, DOPPLER ULTRASOUND REVEALED TRIPHASIC FLOW CURVE WITH STEEP ACCELERATION ALONG THE ENTIRE SUPERFICIAL FEMORAL ARTERY AND THE STENT APPEARED RUPTURED IN THE DISTAL THIRD. MOREOVER, ON-PERFUSED TO-CIRCULAR HALO ALONG THE INDWELLING STENT WITH A DIAMETER OF UP TO 5.5 MM WAS SEEN. ON (B)(6)2021, X -RAY FINDINGS OF RIGHT THIGH REVEALED THE STENT FRACTURE AT THE DISTAL THIRD OF THE STENT AT THE FEMOROPOPLITEAL JUNCTION. ON (B)(6) 2022, 917 DAYS POST INDEX PROCEDURE, COLOR DOPPLER ULTRASOUND OF RIGHT FEMORAL ARTERY SHOWED NO RELEVANT STENOSIS DUE TO MODERATE ATHEROSCLEROTIC CHANGES IN THE PROXIMAL AND MIDDLE THIRD, INDWELLING STENT IN THE DISTAL THIRD OF THE SFA AND SIGNIFICANT STENT FRACTURE WAS SEEN WITH SIGNIFICANT DISLOCATION OF THE DISTAL STENT FRAGMENT IN THE LOWER THIRD OF THE STENT. THE DISTAL FRAGMENT WAS DISPLACED NEARLY 8 MM FROM THE PROXIMAL FRAGMENT. THE ANEURYSMAL EXPANSION WAS OBSERVED 17 MM IN DIAMETER AND 6 CM IN LONGITUDINAL EXTENSION AROUND THE STENT FRACTURE SITE IN THE SFA. DOPPLER SONOGRAPHY SHOWED MARKED TURBULENCE BETWEEN FRAGMENTS, BUT BOTH THE PROXIMAL AND DISTAL STENT FRAGMENTS WERE PERFUSED. BASED ON THE DIAGNOSTIC FINDINGS, THE SUBJECT WAS DIAGNOSED WITH PSEUDOANEURYSMA INSTENT AT BROKEN STENT. ON (B)(6) 2022, THE EVENT (002) WAS CONSIDERED AS RECOVERED/RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED IN A STABLE CONDITION WITH THE ADVICE OF ANTIPLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831977 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0023848277

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H