BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER SL

    MDR report key: 10947065 · Received December 4, 2020

    Report

    Report Number
    2134265-2020-16874
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    May 29, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED TO THE HOSPITAL AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE 90% STENOSED TARGET LESION, WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 10 CM LONG, WITH A REFERENCE VESSEL DIAMETER OF 10 CM, WAS CLASSIFIED UNDER TASC II C LESION. THE LESION WAS TREATED WITH PREDILATION WITH A 4 MM X 150 MM BALLOON WITH A 10% RESIDUAL STENOSIS. FOLLOWING PREDILATION, A GRADE A DISSECTION WAS NOTED AND WAS TREATED WITH A DRUG COATED BALLOON (DCB). A 4 MM X 120 MM RANGER BALLOON AND A 4MM X 80 MM RANGER BALLOON WERE ADVANCED AND SUCCESSFULLY DILATED THE TARGET LESION. POST TREATMENT THERE WAS A 10% STENOSIS RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 337 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED TO THE HOSPITAL WITH RESTENOSIS OF THE TARGET LESION. CONCOMITANT MEDICATION WAS GIVEN TO TREAT THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410909 RANGER SL CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION 26100 4938H18

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention