BEUDAMED
    FDA Adverse Event Death Summary report: Y

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 11547907 · Received March 22, 2021

    Report

    Report Number
    3009784280-2021-00031
    Event Type
    Death
    Date Received
    March 22, 2021
    Date of Event
    October 21, 2019
    Report Date
    March 10, 2021
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H1 (NO. OF EVENTS (NOE) SUMMARIZED): IN THE INITIAL REPORT, THE XML FILE SHOWS THE SUMMARY REPORT AND 123 EVENTS WERE INCLUDED. HOWEVER, THIS WAS INADVERTENTLY INCLUDED DUE TO A SYSTEM ERROR IN THE XML FILE, AS IT WAS NOT VISIBLE IN THE PDF COPY. THIS FIELD SHOULD BE LEFT BLANK.

    Additional Manufacturer Narrative · 0

    BLOCK B: CORRECTED DATE OF EVENT AND LESION SEGMENT. BLOCK C: CORRECTED UNIQUE ID, LOT NUMBER, THERAPY START DATE, THERAPY END DATE, AND EXPIRATION DATE. BLOCK D: CORRECTED MODEL NUMBER, CATALOG NUMBER, LOT NUMBER, UNIQUE ID, IMPLANTED DATE, AND EXPIRATION DATE. BLOCK G3: CORRECT PATIENT ID IS # (B)(6). BLOCK H: CORRECTED DEVICE MANUFACTURE DATE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE ON (B)(6) 2019, A STELLAREX CATHETER WAS USED TO TREAT THE TARGET LESION OF THE RIGHT PROXIMAL SFA. APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED DUE TO COVID-19 ON (B)(6) 2020. THE PHYSICIAN INDICATED THIS IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT, 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. 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) 2019, A STELLAREX CATHETER WAS USED TO TREAT THE TARGET LESION OF THE LEFT MID SFA. APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED DUE TO COVID-19 ON (B)(6) 2020. THE PHYSICIAN INDICATED THIS IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437254 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35SX050120080 F1C19B13A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other