BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER PACLITAXEL-COATED PTA BALLOON CATHETER

    MDR report key: 18806883 · Received February 29, 2024

    Report

    Report Number
    2124215-2024-05278
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    April 10, 2023
    Report Date
    February 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729975946
    PMA / PMN Number
    P190019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER- (B)(6). A2: PATIENT AGE AT TIME OF ENROLLMENT- 65 YEARS OLD.

    Description of Event or Problem · 0

    ELEGANCE STUDY IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 60 MM AND 80% STENOSIS AND TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 2 MM X 1100 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. POST TARGET LESION TREATMENT WAS PERFORMED BY PLACEMENT OF 6 MM X 60 MM NON-BSC BARE METAL STENT AND DILATION USING 5 MM X 60 MM OF MUSTANG PTA BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SECOND TARGET LESION WAS IN THE RIGHT DISTAL SFA WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 60 MM AND 80% STENOSIS AND TASC II B LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 60 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON THE SAME DAY, DURING INDEX PROCEDURE, 80% STENOSIS NOTED IN THE RIGHT MID POPLITEAL ARTERY WAS TREATED WITH 5 MM X 60 MM NON-BSC LITHOTRIPSY BALLOON. POST TREATMENT, FINAL RESIDUAL STENOSIS WAS NOTED TO BE LESS THAN 10%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON 10-APRIL-2023, THE SUBJECT WAS NOTED WITH RIGHT CALF CRAMPING AFTER WALKING 30 FEET AND COLDNESS IN RIGHT FOOT. ON 28-APRIL2023, THE SUBJECT PRESENTED FOR PLANNED RIGHT LOWER EXTREMITY ARTERIAL DUPLEX TEST DUE TO PRIOR NOTED SYMPTOMS OF RIGHT CALF CRAMPING WHILE WALKING MORE THAN 30 FEET WITH RIGHT FOOT COOLER COMPARED TO LEFT FOOT, BUT DENIES RESTING PAIN IN THE FOOT. OF NOTE, ON 01-MARCH-2023, SUBJECT VISITED THE HOSPITAL FOR 12 MONTH FOLLOW UP VISIT, DURING WHICH DUS PERFORMED REVEALED PATENT TARGET LESIONS. ANKLE-BRACHIAL INDEX (ABI) ASSESSMENT WAS NOTED TO BE 0.42 AND 1.05 IN THE RIGHT AND LEFT LEG RESPECTIVELY. TOE BRACHIAL INDEX (TBI) WAS NOTED TO BE 0.18 AND 0.89 IN THE RIGHT AND LEFT LEG, RESPECTIVELY. ON THE SAME DAY, RIGHT LOWER EXTREMITY (TARGET LIMB) ARTERIAL DUPLEX TEST REVEALED MONOPHASIC WAVEFORMS THROUGHOUT RIGHT LOWER EXTREMITY, 50 TO 75% STENOSIS IN RIGHT MID COMMON FEMORAL ARTERY, GREATER THAN 75% STENOSIS IN RIGHT PROXIMAL PROFUNDAL ARTERY, PATENT STENT IN PROXIMAL SFA BUT NO FLOW WAS VISUALIZED IN THE DISTAL SFA STENT WITH FLOW RECONSTITUTION IN PROXIMAL POPLITEAL ARTERY. ON 01-MAY-2023, SUBJECT PRESENTED FOR RIGHT LOWER EXTREMITIES ANGIOGRAM WHICH REVEALED GREATER THAN 90% STENOSIS IN PROXIMAL EDGE OF THE RIGHT PROXIMAL SFA STENT BUT THE REST OF ARTERY WAS DIFFUSELY DISEASED, OCCLUSION IN MID PORTION OF DISTAL SFA, 60% STENOSIS IN PROXIMAL AND MID POPLITEAL ARTERY, OCCLUDED PERONEAL ARTERY WITH RECONSTITUTION OF THE PROXIMAL POPLITEAL ARTERY, TIBIAL ARTERIES AND 2 VESSEL TIBIAL RUNOFF. ON THE SAME DAY, GREATER THAN 90% STENOSIS NOTED IN PROXIMAL EDGE OF THE RIGHT PROXIMAL SFA STENT WAS TREATED BY ATHERECTOMY USING 6 FRENCH NON-BSC DEVICE FOLLOWED BY DRUG COATED BALLOON ANGIOPLASTY USING 4 MM X 100 MM NON-BSC BALLOON IN THE RIGHT PROXIMAL SFA. SUBSEQUENTLY, OCCLUSION NOTED IN RIGHT DISTAL SFA WAS TREATED BY DRUG COATED BALLOON ANGIOPLASTY USING 4 MM X 100 MM NON-BSC BALLOON. POST TREATMENT, FINAL RESIDUAL STENOSIS NOTED IN RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY WAS 30% AND IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WAS 10%. IN ADDITION, DURING REVASCULARIZATION PROCEDURE, 60% STENOSIS IN RIGHT PROXIMAL AND MID POPLITEAL ARTERY WERE TREATED BY ATHERECTOMY USING 6 FRENCH NON-BSC DEVICE FOLLOWED BY DRUG COATED BALLOON ANGIOPLASTY USING 4 MM X 100 MM NON-BSC BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON 01-MAY-2023, THE EVENT WAS CONSIDERED RESOLVED WITH NO PERI-PROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927494 RANGER PACLITAXEL-COATED PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU BOSTON SCIENTIFIC CORPORATION 1973-03 00046H22 08714729975946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention