BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 7127277 · Received December 18, 2017

    Report

    Report Number
    3009784280-2017-00106
    Event Type
    Death
    Date Received
    December 18, 2017
    Date of Event
    November 28, 2016
    Report Date
    December 1, 2017
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S CAUSE OF DEATH WAS UNRELATED TO THE STELLAREX DEVICE OR PROCEDURE. THIS IS BEING REPORTED AS A FOLLOW-UP TO THE CLINICAL REGISTRY. PATIENT INFORMATION REGARDING RELEVANT TESTS OR LABORATORY DATA IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. THE PATIENT'S CAUSE OF DEATH WAS UNRELATED TO THE STELLAREX DEVICE OR PROCEDURE, THUS THE PACLITAXEL DRUG DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH. (B)(6). PMA NUMBER IS NOT APPLICABLE. THE DEVICE IS COMMERCIAL PRODUCT WITH A CE MARK THAT WAS USED AS PART OF A CLINICAL REGISTRY. / COMBINATION PRODUCT IS APPLICABLE. DURING THE INDEX PROCEDURE, THE PRODUCT WORKED AS INTENDED, THUS NO PRODUCT EVALUATION WAS REQUIRED. PER THE IFU, DEATH IS LISTED AS A POTENTIAL COMPLICATIONS/ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE ON (B)(6) 2016, TWO STELLAREX CATHETERS WERE USED TO TREAT THE TARGET LESION OF THE RIGHT MID AND DISTAL SFA. APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED ON (B)(6) 2017, DUE TO METASTATIC BRONCHIAL CARCINOMA. THE PHYSICIAN INDICATED THIS IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905775 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35SX060080080 FWX16G13A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other