BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 11935784 · Received June 3, 2021

    Report

    Report Number
    3009784280-2021-00055
    Event Type
    Death
    Date Received
    June 3, 2021
    Date of Event
    August 9, 2018
    Report Date
    May 12, 2021
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: ADDED CODE 1802 (DEATH). ALTHOUGH THE CAUSE OF DEATH IS UNRELATED TO THE STUDY DEVICE, DEATH IS LISTED IN THE IFU AS A POTENTIAL COMPLICATIONS/ ADVERSE EVENTS. COMPONENT CODES INTENTIONALLY LEFT BLANK. NO DEVICE MALFUNCTION WAS REPORTED DURING THE INDEX PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S ETHNICITY AND RACE ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. 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)/ 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 AND THE DEVICE WAS DISCARDED, THUS NO PRODUCT EVALUATION WAS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE ON (B)(6) 2018, A STELLAREX CATHETER WAS USED TO TREAT THE TARGET LESION OF THE RIGHT MID SFA. APPROXIMATELY 31 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED DUE TO GANGRENE, PERIPHERAL VASCULAR DISEASE, COLON CANCER, DIABETES MELLITIS TYPE II, FRAILTY, AND COPD ON (B)(6) 2021. THE PHYSICIAN INDICATED THIS IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823451 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35SX060120135 FL518E22A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other