BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER PACLITAXEL-COATED PTA BALLOON CATHETER

    MDR report key: 12558937 · Received September 30, 2021

    Report

    Report Number
    2134265-2021-12116
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    August 20, 2021
    Report Date
    November 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729976028
    PMA / PMN Number
    P190019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS 1: (B)(6).

    Description of Event or Problem · 0

    ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON, AND TWO ELUVIA DRUG ELUTING STENTS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE ENTIRE LENGTH OF LEFT SFA (PROXIMAL, MID, DISTAL SFA) EXTENDING INTO LEFT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.5 MM WITH LESION LENGTH OF 360 M AND 100% STENOSIS. PRE-DILATATION WAS PERFORMED, AND TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICES, RANGER DRUG COATED BALLOON 5 MM X 150 MM AND ELUVIA DRUG ELUTING STENTS OF SIZES 6 MM X 120 MM AND 6 MM X 100 MM WERE IMPLANTED. POST TARGET LESION TREATMENT WAS DONE BY STENTING WITH NON-BSC DRUG ELUTING STENT DUE TO DISSECTION OF GRADE E AND RESIDUAL STENOSIS NOTED. FOLLOWING POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE COMPLICATION WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. IT WAS FURTHER REPORTED THAT DURING OR AFTER INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH COMPLICATION OF DISSECTION WITH SEVERITY GRADE E DUE TO A NON-BSC DEVICE. SUBSEQUENTLY, THE SUBJECT WAS TREATED WITH BAILOUT STENT NON-BSC DRUG ELUTING STENT OF SIZE 4.5 MM X 100 MM AND THE COMPLICATION WAS CONSIDERED RESOLVED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER NAME AND ADDRESS: (B)(6).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON, AND TWO ELUVIA DRUG ELUTING STENTS ON (B)(6) 2021 AS A PART OF THE (B)(6) CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE ENTIRE LENGTH OF LEFT SFA (PROXIMAL, MID, DISTAL SFA) EXTENDING INTO LEFT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.5 MM WITH LESION LENGTH OF 360 M AND 100% STENOSIS. PRE-DILATATION WAS PERFORMED, AND TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICES, RANGER DRUG COATED BALLOON 5 MM X 150 MM AND ELUVIA DRUG ELUTING STENTS OF SIZES 6 MM X 120 MM AND 6 MM X 100 MM WERE IMPLANTED. POST TARGET LESION TREATMENT WAS DONE BY STENTING WITH NON-BSC DRUG ELUTING STENT DUE TO DISSECTION OF GRADE E AND RESIDUAL STENOSIS NOTED. FOLLOWING POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE COMPLICATION WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449221 RANGER PACLITAXEL-COATED PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU BOSTON SCIENTIFIC CORPORATION 1973-03 0027264977 08714729976028

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention