BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 8382282 · Received March 1, 2019

    Report

    Report Number
    3009784280-2019-00019
    Event Type
    Death
    Date Received
    March 1, 2019
    Date of Event
    April 16, 2018
    Report Date
    January 30, 2019
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S CAUSE OF DEATH WAS UNRELATED TO THE STUDY DEVICE OR PROCEDURE. THIS IS BEING REPORTED AS A FOLLOW-UP TO THE CLINICAL REGISTRY. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. REPORT SOURCE FOREIGN- (B)(6) (GBR)/ STUDY NAME: (B)(6): PATIENT ID# (B)(6). PMA NUMBER IS NOT APPLICABLE. THE DEVICE IS A COMMERCIAL PRODUCT WITH A CE MARK THAT WAS USED AS PART OF A CLINICAL REGISTRY. DURING THE INDEX PROCEDURE, THE PRODUCT WORKED AS INTENDED. THE DEVICE WAS DISCARDED, THUS NO PRODUCT EVALUATION WAS PERFORMED. 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) 2018, TWO STELLAREX CATHETERS WERE USED TO TREAT THE TARGET LESION OF THE LEFT PROXIMAL SFA. APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED ADVANCED SUPRAGLOTTIC TUMOR AND EXPIRED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176161 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35SX060120135 FJW17L29A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other