BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 8705225 · Received June 17, 2019

    Report

    Report Number
    3009784280-2019-00398
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    October 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B5: CORRECTED APPROXIMATE MONTHS FROM 36 MONTHS TO 38 MONTHS.

    Description of Event or Problem · 0

    APPROXIMATELY 38 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS.

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT, OUTCOMES TO ADVERSE EVENT: THE PATIENT REQUIRED REVASCULARIZATION OF THE TARGET VESSEL. THIS IS BEING REPORTED AS A FOLLOW-UP TO THE CLINICAL STUDY. 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 LEFT MID SFA. APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. A REVASCULARIZATION OF THE TARGET VESSEL WAS PERFORMED ON (B)(6) 2018. APPROXIMATELY 2 MONTHS LATER, THE PATIENT EXPERIENCED A RESTENOSIS. A SUCCESSFUL REVASCULARIZATION OF THE TARGET VESSEL 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
    498692 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35DC05008013IO 14M1050801

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R