BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 17031683 · Received May 31, 2023

    Report

    Report Number
    2124215-2023-27268
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    April 19, 2023
    Report Date
    October 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    UDI-DI
    08714729876854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER - (B)(6). A2: AGE AT TIME OF EVENT - 69 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER - (B)(6). A2: AGE AT TIME OF EVENT - (B)(6) YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER - (B)(6). A2: AGE AT TIME OF EVENT - 69 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT RE-OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA EXTENDING UP TO LEFT DISTAL SFA WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 240 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BOSTON SCIENTIFIC BALLOON CATHETER AND 5 MM X 220 MM AND 6 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON CATHETERS. TREATMENT OF TARGET LESION WAS PERFORMED BY THE PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING POST DILATION WITH 6 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON CATHETER, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. RESIDUAL STENOSIS WAS NOTED DURING INDEX PROCEDURE AND IN RESPONSE BAILOUT STENT WAS USED TO RESOLVE THE COMPLICATION. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH THE SYMPTOMS RELATED TO LOWER EXTREMITY ARTERIOSCLEROSIS OBLITERATION AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT ON THE SAME DAY. ON (B)(6) 2023, 220 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT MID SFA AND LEFT DISTAL SFA WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND DRUG COATED BALLOON ANGIOPLASTY. POST TREATMENT, FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. IT WAS FURTHER REPORTED THAT THE BAILOUT STENT USED DURING THE INDEX PROCEDURE WAS THE 6 MM X 120 MM ELUVIA DRUG-ELUTING STUDY STENT. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH THE SYMPTOMS RELATED TO INTERMITTENT CLAUDICATION FOR 4 MONTHS AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT ON THE SAME DAY. ON THE SAME DAY, THE SUBJECT STATED THAT HE WAS EXPERIENCING LEFT CALF PAIN, ASTHENIA, WITH NUMBNESS AND COLDNESS OF THE LEFT DORSUM OF FOOT DURING WALKING ABOUT 50 M AND THE SYMPTOMS WOULD BE RELIEVED AFTER RESTING FOR MORE THAN 10 MIN AND THE SUBJECT COULD CONTINUE WALKING. ON (B)(6) 2023, LOWER LIMB CT ANGIOGRAPHY AND ULTRASOUND OF LEFT FEMORAL ARTERY SHOWED STENT OCCLUSION. ON (B)(6) 2023, 220 DAYS POST INDEX PROCEDURE, THROMBOTIC OCCLUSION NOTED IN THE LEFT MID SFA AND LEFT DISTAL SFA WERE TREATED WITH PERCUTANEOUS PERIPHERAL ARTERIAL THROMBECTOMY USING A NON-BOSTON SCIENTIFIC THROMBUS SUCTION DEVICE FOLLOWED BY PRE-DILATION THAT WAS PERFORMED USING A 4 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON, FOLLOWED BY A 5 MM X 150 MM BALLOON AND A 6 MM X 220 MM BALLOON. POST TREATMENT, FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. DURING POST PROCEDURE ANGIOGRAPHY, LOCAL NON-FLOW-LIMITING DISSECTIONS WERE NOTED, AND THE PROTECTIVE UMBRELLA PLACED IN THE POPLITEAL ARTERY BEFORE THE PROCEDURE WAS EVACUATED. ANOTHER ANGIOGRAPHY WAS PERFORMED WHICH SHOWED NO OBSTRUCTION. ON (B)(6) 2023, THE SUBJECT SYMPTOMS POST PROCEDURE WERE IMPROVED, AND THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. IT WAS FURTHER REPORTED THAT THE TARGET LESION DID NOT INCLUDE THE PROXIMAL SFA. THE ELUVIA STENT WAS IMPLANTED IN THE MID TO DISTAL SFA.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL STUDYIT WAS REPORTED THAT RE-OCCLUSION OCCURRED.THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA EXTENDING UP TO LEFT DISTAL SFA WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 240 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BOSTON SCIENTIFIC BALLOON CATHETER AND 5 MM X 220 MM AND 6 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON CATHETERS. TREATMENT OF TARGET LESION WAS PERFORMED BY THE PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING POST DILATION WITH 6 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON CATHETER, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. RESIDUAL STENOSIS WAS NOTED DURING INDEX PROCEDURE AND IN RESPONSE BAILOUT STENT WAS USED TO RESOLVE THE COMPLICATION. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL.ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH THE SYMPTOMS RELATED TO LOWER EXTREMITY ARTERIOSCLEROSIS OBLITERATION AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT ON THE SAME DAY. ON (B)(6) 2023, 220 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT MID SFA AND LEFT DISTAL SFA WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND DRUG COATED BALLOON ANGIOPLASTY. POST TREATMENT, FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY.IT WAS FURTHER REPORTED THAT THE BAILOUT STENT USED DURING THE INDEX PROCEDURE WAS THE 6 MM X 120 MM ELUVIA DRUG-ELUTING STUDY STENT. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH THE SYMPTOMS RELATED TO INTERMITTENT CLAUDICATION FOR 4 MONTHS AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT ON THE SAME DAY. ON THE SAME DAY, THE SUBJECT STATED THAT HE WAS EXPERIENCING LEFT CALF PAIN, ASTHENIA, WITH NUMBNESS AND COLDNESS OF THE LEFT DORSUM OF FOOT DURING WALKING ABOUT 50 M AND THE SYMPTOMS WOULD BE RELIEVED AFTER RESTING FOR MORE THAN 10 MIN AND THE SUBJECT COULD CONTINUE WALKING. ON (B)(6) 2023, LOWER LIMB CT ANGIOGRAPHY AND ULTRASOUND OF LEFT FEMORAL ARTERY SHOWED STENT OCCLUSION. ON (B)(6) 2023, 220 DAYS POST INDEX PROCEDURE, THROMBOTIC OCCLUSION NOTED IN THE LEFT MID SFA AND LEFT DISTAL SFA WERE TREATED WITH PERCUTANEOUS PERIPHERAL ARTERIAL THROMBECTOMY USING A NON-BOSTON SCIENTIFIC THROMBUS SUCTION DEVICE FOLLOWED BY PRE-DILATION THAT WAS PERFORMED USING A 4 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON, FOLLOWED BY A 5 MM X 150 MM BALLOON AND A 6 MM X 220 MM BALLOON. POST TREATMENT, FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. DURING POST PROCEDURE ANGIOGRAPHY, LOCAL NON-FLOW-LIMITING DISSECTIONS WERE NOTED, AND THE PROTECTIVE UMBRELLA PLACED IN THE POPLITEAL ARTERY BEFORE THE PROCEDURE WAS EVACUATED. ANOTHER ANGIOGRAPHY WAS PERFORMED WHICH SHOWED NO OBSTRUCTION. ON (B)(6) 2023, THE SUBJECT SYMPTOMS POST PROCEDURE WERE IMPROVED, AND THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT RE-OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA EXTENDING UP TO LEFT DISTAL SFA WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 240 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BOSTON SCIENTIFIC BALLOON CATHETER AND 5 MM X 220 MM AND 6 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON CATHETERS. TREATMENT OF TARGET LESION WAS PERFORMED BY THE PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING POST DILATION WITH 6 MM X 220 MM NON-BOSTON SCIENTIFIC BALLOON CATHETER, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. RESIDUAL STENOSIS WAS NOTED DURING INDEX PROCEDURE AND IN RESPONSE BAILOUT STENT WAS USED TO RESOLVE THE COMPLICATION. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH THE SYMPTOMS RELATED TO LOWER EXTREMITY ARTERIOSCLEROSIS OBLITERATION AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT ON THE SAME DAY. ON (B)(6) 2023, 220 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT MID SFA AND LEFT DISTAL SFA WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND DRUG COATED BALLOON ANGIOPLASTY. POST TREATMENT, FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829266 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0028123265 08714729876854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H