BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER PACLITAXEL-COATED PTA BALLOON CATHETER

    MDR report key: 17451719 · Received August 3, 2023

    Report

    Report Number
    2124215-2023-38359
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729976042
    PMA / PMN Number
    P190019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER- (B)(6). A2: PATIENT AGE AT TIME OF ENROLLMENT- 71 YEARS OLD.

    Additional Manufacturer Narrative · 0

    B5 UPDATED. A1: PATIENT IDENTIFIER- (B)(6). A2: PATIENT AGE AT TIME OF ENROLLMENT- 71 YEARS OLD.

    Description of Event or Problem · 0

    ELEGANCE STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED SYMPTOMS OF CLAUDICATION AND 70% STENOSIS WAS REVEALED IN THE TARGET LESION, AS WELL AS IN-STENT OCCLUSION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT COMMON FEMORAL ARTERY, RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY, RIGHT PROXIMAL POPLITEAL ARTERY EXTENDING TO RIGHT MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 380 MM AND 100 % STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, PRE-DILATION WAS PERFORMED USING 3.5 MM X 30 MM NON-BOSTON SCIENTIFIC (BSC) PTA BALLOON, 6 MM X 100 MM NON-BSC PTA BALLOON AND 6 MM X 80 MM NON-BSC PTA BALLOON CATHETER. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5 MM X 200 MM AND 6 MM X 200 MM RANGER DRUG-COATED BALLOON. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. PER EDC, ON (B)(6) 2023, THE SUBJECT VISITED HOSPITAL WITH COMPLAINTS OF SWELLING AND NONHEALING ULCER OF RIGHT LOWER EXTREMITY WITH CLAUDICATION. SUBSEQUENTLY, SUBJECT WAS TRIAGED TO THE CATHETERIZATION LAB FOR THE LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE INTERVENTION WHICH REVEALED 70% STENOSIS IN RIGHT COMMON FEMORAL ARTERY, IN-STENT OCCLUSION OF SFA, OCCLUSION OF MID ANTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL ARTERY. PER EDC, ON (B)(6) 2023, 259 DAYS POST INDEX PROCEDURE, STENOSIS NOTED IN THE COMMON FEMORAL ARTERY AND OCCLUSION NOTED IN THE ENTIRE LENGTH OF RIGHT SUPERFICIAL FEMORAL ARTERY WERE TREATED BY ATHERECTOMY WITH JETSTREAM 2.4/3.4 ATHERECTOMY DEVICE. FOLLOWING WHICH, BALLOON DILATION WAS PERFORMED IN RIGHT SFA AND POPLITEAL ARTERY USING 4 MMX 300 MM NON-BSC BALLOON. SUBSEQUENTLY, PERIPHERAL ANGIOGRAM PERFORMED REVEALED PERSISTENT STENOSIS IN THE COMMON FEMORAL ARTERY AND IN-STENT STENOSIS IN THE SFA. WHICH WAS TREATED BY 5 MM X 60 MM NON-BSC BALLOON ANGIOPLASTY, FOLLOWED BY BALLOON ANGIOPLASTY USING 6.0 X 120 MM NON-BSC BALLOON, AND 6.0 MM X 200 MM RANGER DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. PER EDC, ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED.

    Description of Event or Problem · 0

    ELEGANCE STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED SYMPTOMS OF CLAUDICATION AND 70% STENOSIS WAS REVEALED IN THE TARGET LESION, AS WELL AS IN-STENT OCCLUSION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT COMMON FEMORAL ARTERY, RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY, RIGHT PROXIMAL POPLITEAL ARTERY EXTENDING TO RIGHT MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 380 MM AND 100 % STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, PRE-DILATION WAS PERFORMED USING 3.5 MM X 30 MM NON-BOSTON SCIENTIFIC (BSC) PTA BALLOON, 6 MM X 100 MM NON-BSC PTA BALLOON AND 6 MM X 80 MM NON-BSC PTA BALLOON CATHETER. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5 MM X 200 MM AND 6 MM X 200 MM RANGER DRUG-COATED BALLOON. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON (B)(6)2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2023, THE SUBJECT VISITED HOSPITAL WITH COMPLAINTS OF SWELLING AND NONHEALING ULCER OF RIGHT LOWER EXTREMITY WITH CLAUDICATION. SUBSEQUENTLY, SUBJECT WAS TRIAGED TO THE CATHETERIZATION LAB FOR THE LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE INTERVENTION WHICH REVEALED 70% STENOSIS IN RIGHT COMMON FEMORAL ARTERY, IN-STENT OCCLUSION OF SFA, OCCLUSION OF MID ANTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL ARTERY. ON (B)(6) 2023, 259 DAYS POST INDEX PROCEDURE, STENOSIS NOTED IN THE COMMON FEMORAL ARTERY AND OCCLUSION NOTED IN THE ENTIRE LENGTH OF RIGHT SUPERFICIAL FEMORAL ARTERY WERE TREATED BY ATHERECTOMY WITH JETSTREAM 2.4/3.4 ATHERECTOMY DEVICE. FOLLOWING WHICH, BALLOON DILATION WAS PERFORMED IN RIGHT SFA AND POPLITEAL ARTERY USING 4 MMX 300 MM NON-BSC BALLOON. SUBSEQUENTLY, PERIPHERAL ANGIOGRAM PERFORMED REVEALED PERSISTENT STENOSIS IN THE COMMON FEMORAL ARTERY AND IN-STENT STENOSIS IN THE SFA. WHICH WAS TREATED BY 5 MM X 60 MM NON-BSC BALLOON ANGIOPLASTY, FOLLOWED BY BALLOON ANGIOPLASTY USING 6.0 X 120 MM NON-BSC BALLOON, AND 6.0 MM X 200 MM RANGER DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. PER EDC, ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY, RIGHT PROXIMAL POPLITEAL ARTERY EXTENDING TO RIGHT MID POPLITEAL ARTERY. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE LITHOTRIPSY WAS PERFORMED WITH 5 MM X 60 MM NON-BOSTON SCIENTIFIC (BSC) LITHOTRIPSY DEVICE AND ATHERECTOMY WAS PERFORMED WITH NON-BSC ATHERECTOMY DEVICE, PRE-DILATION WAS PERFORMED USING 3.5 MM X 30 MM NON-BSC PTA BALLOON, 6 MM X 100 MM NON-BSC PTA BALLOON AND 6 MM X 80 MM NON-BSC PTA BALLOON CATHETER. ON (B)(6) 2023, THE SUBJECT VISITED HOSPITAL WITH COMPLAINTS OF SWELLING AND NONHEALING ULCER OF RIGHT LOWER EXTREMITY WITH CLAUDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281050 RANGER PACLITAXEL-COATED PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU BOSTON SCIENTIFIC CORPORATION 1973-03 03260H22 08714729976042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention