BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA XL

    MDR report key: 21684463 · Received March 24, 2025

    Report

    Report Number
    2124215-2025-17189
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    October 1, 2018
    Report Date
    March 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HSU TS, WENG SC, LIN YH, CHEN CL, TSAO SH, TSAI HY, JUANG HH, CHANG PL, HOU CP. SURGICAL OUTCOMES OF ENDOSCOPIC ENUCLEATION OF THE PROSTATE IN COMMUNITY AGING MALES WITH OR WITHOUT PREOPERATIVE URINARY RETENTION. INT UROL NEPHROL. 2024 AUG;56(8):2513-2519. DOI: 10.1007/S11255-024-04007-7. EPUB 2024 APR 2. PMID: 38564078; PMCID: PMC11266197.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE INTERNATIONAL UROLOGY AND NEPHROLOGY JOURNAL THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO INVESTIGATE THE SURGICAL OUTCOMES OF ENDOSCOPIC ENUCLEATION OF THE PROSTATE IN OLDER MALES WITH OR WITHOUT PREOPERATIVE URINARY RETENTION. PATIENTS WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) WHO UNDERWENT EITHER THULIUM: YAG LASER (VELA XL, THULEP), OR BIPOLAR PLASMA ENUCLEATION OF THE PROSTATE (B-TUEP) WERE SELECTED FOR THIS STUDY. THE PATIENT DATA SPANS FROM OCTOBER 2018 TO JULY 2022 AND THERE WERE 207 PATIENTS INCLUDED. ALL THE PATIENTS WERE OPERATED ON BY A SINGLE SKILLED SURGEON. THE STUDIED PATIENTS WERE CATEGORIZED INTO TWO GROUPS, NAMELY THE URINARY RETENTION (UR) GROUP AND THE NON-UR GROUP, ON THE BASIS OF WHETHER THEY EXPERIENCED UR IN THE 1 MONTH PRECEDING THEIR SURGERY. INTRAOPERATIVE AND PERIOPERATIVE DATA FOR THE THULEP CASES INDICATES THE FOLLOWING ADVERSE EVENTS: RE-CATHETERIZATION WITHIN 1 MONTH (6 FOR NON-UR AND 0 FOR UR), URINARY TRACT INFECTIONS WITHIN 1 MONTH (29 FOR NON-UR AND 6 FOR UR), AND RETURNING TO THE EMERGENCY ROOM WITHIN 1 MONTH (6 FOR NON-UR AND 2 FOR UR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100312 VELA XL POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION UNK-P-VELA_XL_4101_CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O