BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 8705200 · Received June 17, 2019

    Report

    Report Number
    3009784280-2019-00402
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    April 19, 2018
    Report Date
    April 19, 2018
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT, OUTCOMES TO ADVERSE EVENT: THE PATIENT REQUIRED REVASCULARIZATION OF THE TARGET LESION. THIS IS BEING REPORTED AS A FOLLOW-UP TO THE CLINICAL STUDY. TESTS/LABORATORY DATA AND DATES: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. UDI #, PMA/510K #: UDI AND PMA NUMBERS ARE NOT APPLICABLE. THIS DEVICE WAS USED IN CLINICAL APPLICATION PRIOR TO BEING AVAILABLE IN THE US. REPORT SOURCE: FOREIGN- (B)(6) / STUDY NAME: (B)(6), PATIENT ID # (B)(6). DEVICE EVALUATED BY MFR: DURING THE INDEX PROCEDURE, THE PRODUCT WORKED AS INTENDED, THUS NO PRODUCT EVALUATION WAS REQUIRED. PER THE IFU, RESTENOSIS IS LISTED AS A POTENTIAL COMPLICATIONS/ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT DURING THE INDEX PROCEDURE ON (B)(6) 2015, TWO STELLAREX CATHETERS WERE USED TO TREAT THE TARGET LESION OF THE RIGHT MID SFA. APPROXIMATELY 37 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. A SUCCESSFUL REVASCULARIZATION OF THE TARGET LESION WAS PERFORMED ON (B)(6) 2018. THE PHYSICIAN INDICATED THIS IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498466 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35DC06008013IO 14M1360802

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R