BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 17686760 · Received September 5, 2023

    Report

    Report Number
    2124215-2023-47381
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    November 2, 2022
    Report Date
    July 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    UDI-DI
    08714729876700
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: (B)(6). A2: AGE AT TIME OF EVENT: 57 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Additional Manufacturer Narrative · 0

    A2: AGE AT TIME OF EVENT: 57 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT IN-STENT OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND A 6.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 50 MM WITH 95% STENOSIS AND WAS CLASSIFIED AS A TASC II A LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED WITH A 5.0 MM X 40 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE: 7 MM X 60 MM ELUVIA DRUG-ELUTING STENT. POST-DILATION WAS PERFORMED WITH A 7.0 MM X 40 MM MUSTANG OTW PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, DURING STUDY SPECIFIC 12-MONTH FOLLOW UP VISIT, RIGHT LOWER EXTREMITY ARTERIAL DUPLEX WAS PERFORMED WHICH REVEALED OCCLUDED STENT FROM RIGHT PROXIMAL SFA TO RIGHT MID SFA WITH RE-CONSTITUTION IN THE RIGHT DISTAL SFA AND 20-49% STENOSIS IN RIGHT PROFUNDA FEMORIS ARTERY. BASED ON THESE FINDINGS, NO ACTION WAS TAKEN AT THAT TIME. ON (B)(6) 2023, THE SUBJECT VISITED HOSPITAL WITH COMPLAINTS OF RIGHT LEG PAIN AND DISCOMFORT IN THE RIGHT LOWER EXTREMITY, MOSTLY IN CALF. PHYSICAL EXAMINATION REVEALED FEMORAL PULSES INTACT BILATERALLY, NON-PALPABLE PEDAL PULSES BILATERALLY, PALPABLE LEFT PT PULSES BILATERALLY, FAINT DOPPLERABLE RIGHT DISTAL ANTERIOR TIBIAL DORSALIS PEDAL PULSE AND NO SIGNS OF CYANOSIS AND COOLNESS NOTED. BASED ON THESE FINDINGS, RIGHT FEMORAL-POPLITEAL ARTERY BYPASS SURGERY WAS PLANNED. ON (B)(6) 2023, SUBJECT VISITED THE HOSPITAL FOR PLANNED BYPASS SURGERY AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER TREATMENT. ON (B)(6) 2023, 525 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE RIGHT PROXIMAL SFA WAS TREATED WITH ENDARTERECTOMY AND RIGHT FEMORAL ARTERY TO POPLITEAL ARTERY BYPASS SURGERY USING A 6 MM NON-BOSTON SCIENTIFIC VASCULAR GRAFT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. SUBSEQUENTLY, PLAQUE NOTED IN THE RIGHT COMMON ARTERY AND RIGHT PROFUNDA FEMORIS ARTERY WAS TREATED WITH ENDARTERECTOMY. POST PROCEDURE, THE SUBJECT HAD PALPABLE DORSALIS PEDIS AND POSTERIOR TIBIAL PULSE. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED AND ON THE SAME DAY, SUBJECT WAS DISCHARGED ON CLOPIDOGREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN-STENT OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON (B)(6) 2021 AS A PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND A 6.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 50 MM WITH 95% STENOSIS AND WAS CLASSIFIED AS A TASC II A LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED WITH A 5.0 MM X 40 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE: 7 MM X 60 MM ELUVIA DRUG-ELUTING STENT. POST-DILATION WAS PERFORMED WITH A 7.0 MM X 40 MM MUSTANG OTW PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, DURING STUDY SPECIFIC 12-MONTH FOLLOW UP VISIT, RIGHT LOWER EXTREMITY ARTERIAL DUPLEX WAS PERFORMED WHICH REVEALED OCCLUDED STENT FROM RIGHT PROXIMAL SFA TO RIGHT MID SFA WITH RE-CONSTITUTION IN THE RIGHT DISTAL SFA AND 20-49% STENOSIS IN RIGHT PROFUNDA FEMORIS ARTERY. BASED ON THESE FINDINGS, NO ACTION WAS TAKEN AT THAT TIME. ON (B)(6) 2023, THE SUBJECT VISITED HOSPITAL WITH COMPLAINTS OF RIGHT LEG PAIN AND DISCOMFORT IN THE RIGHT LOWER EXTREMITY, MOSTLY IN CALF. PHYSICAL EXAMINATION REVEALED FEMORAL PULSES INTACT BILATERALLY, NON-PALPABLE PEDAL PULSES BILATERALLY, PALPABLE LEFT PT PULSES BILATERALLY, FAINT DOPPLERABLE RIGHT DISTAL ANTERIOR TIBIAL DORSALIS PEDAL PULSE AND NO SIGNS OF CYANOSIS AND COOLNESS NOTED. BASED ON THESE FINDINGS, RIGHT FEMORAL-POPLITEAL ARTERY BYPASS SURGERY WAS PLANNED. ON (B)(6) 2023, SUBJECT VISITED THE HOSPITAL FOR PLANNED BYPASS SURGERY AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER TREATMENT. ON (B)(6) 2023, 525 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE RIGHT PROXIMAL SFA WAS TREATED WITH ENDARTERECTOMY AND RIGHT FEMORAL ARTERY TO POPLITEAL ARTERY BYPASS SURGERY USING A 6 MM NON-BOSTON SCIENTIFIC VASCULAR GRAFT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. SUBSEQUENTLY, PLAQUE NOTED IN THE RIGHT COMMON ARTERY AND RIGHT PROFUNDA FEMORIS ARTERY WAS TREATED WITH ENDARTERECTOMY. POST PROCEDURE, THE SUBJECT HAD PALPABLE DORSALIS PEDIS AND POSTERIOR TIBIAL PULSE. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED AND ON THE SAME DAY, SUBJECT WAS DISCHARGED ON CLOPIDOGREL. IT WAS FURTHER REPORTED THAT THE PER THE INVESTIGATOR, THIS EVENT WAS NOT RELATED TO THE ELUVIA STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156322 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24657 0024439740 08714729876700

    Patients

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