BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 20465252 · Received October 16, 2024

    Report

    Report Number
    2124215-2024-64464
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 4, 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: THE SUBJECT WAS 74 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B5 - DESCRIBE EVENT OR PROBLEM. A1 - PATIENT IDENTIFIER: (B)(6). A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 74 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - H6: EVALUATION METHOD CODES, EVALUATION RESULTS CODES, EVALUATION CONCLUSION CODES. A1: PATIENT IDENTIFIER: (B)(6). A2: AGE AT TIME OF EVENT: THE SUBJECT WAS 74 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. E1: INITIAL REPORTER FACILITY NAME: AFFILIATED HOSPITAL OF (B)(6).

    Description of Event or Problem · 0

    ELEGANCE CLINICAL STUDY: IT WAS REPORTED THAT 121 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED ARTERIOSCLEROSIS OBLITERANS OF THE LOWER EXTREMITY WITH GANGRENE, AND RIGHT CALF AMPUTATION WAS PERFORMED AS A RESULT. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT DISTAL SFA WITH A 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND A 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF A 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING, POST-DILATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. DURING THE TREATMENT OF THE TARGET LESION, DISSECTION OF GRADE B WAS NOTED AND IN RESPONSE, BAILOUT STENT WAS PLACED. THE COMPLICATION OF DISSECTION WAS RESOLVED. THE DEVICE RESPONSIBLE FOR THE DISSECTION WAS UNKNOWN. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2024, 121 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO ARTERIOSCLEROSIS OBLITERANS OF THE LOWER EXTREMITY WITH GANGRENE. IN (B)(6)2024, THE SUBJECT WAS ADMITTED TO HOSPITAL. IN RESPONSE TO THE EVENT, RIGHT CALF AMPUTATION WAS PERFORMED WITH FLAP-PLASTY AND MUSCLE RELEASE. ON AN UNKNOWN DATE IN 2024, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 121 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED ARTERIOSCLEROSIS OBLITERANS OF THE LOWER EXTREMITY WITH GANGRENE, AND RIGHT CALF AMPUTATION WAS PERFORMED AS A RESULT. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT DISTAL SFA WITH A 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND A 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF A 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING, POST-DILATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. DURING THE TREATMENT OF THE TARGET LESION, DISSECTION OF GRADE B WAS NOTED AND IN RESPONSE, BAILOUT STENT WAS PLACED. THE COMPLICATION OF DISSECTION WAS RESOLVED. THE DEVICE RESPONSIBLE FOR THE DISSECTION WAS UNKNOWN. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2024, 121 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO ARTERIOSCLEROSIS OBLITERANS OF THE LOWER EXTREMITY WITH GANGRENE. IN (B)(6) 2024, THE SUBJECT WAS ADMITTED TO HOSPITAL. IN RESPONSE TO THE EVENT, RIGHT CALF AMPUTATION WAS PERFORMED WITH FLAP-PLASTY AND MUSCLE RELEASE. ON AN UNKNOWN DATE IN 2024, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. IT WAS FURTHER REPORTED THAT THE EVENT RESOLVED ON (B)(6) 2024.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT 121 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED ARTERIOSCLEROSIS OBLITERANS OF THE LOWER EXTREMITY WITH GANGRENE, AND RIGHT CALF AMPUTATION WAS PERFORMED AS A RESULT. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT DISTAL SFA WITH A 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND A 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF A 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING, POST-DILATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. DURING THE TREATMENT OF THE TARGET LESION, DISSECTION OF GRADE B WAS NOTED AND IN RESPONSE, BAILOUT STENT WAS PLACED. THE COMPLICATION OF DISSECTION WAS RESOLVED. THE DEVICE RESPONSIBLE FOR THE DISSECTION WAS UNKNOWN. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2024, 121 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO ARTERIOSCLEROSIS OBLITERANS OF THE LOWER EXTREMITY WITH GANGRENE. ON (B)(6) 2024, THE SUBJECT WAS ADMITTED TO HOSPITAL. IN RESPONSE TO THE EVENT, RIGHT CALF AMPUTATION WAS PERFORMED WITH FLAP-PLASTY AND MUSCLE RELEASE. ON AN UNKNOWN DATE IN 2024, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248661 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0030482650 08714729876854

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| S| H RANGER DRUG COATED BALLOON.| RANGER DRUG COATED BALLOON.| RANGER DRUG COATED BALLOON.