BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 20532055 · Received October 25, 2024

    Report

    Report Number
    2124215-2024-66856
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    January 1, 2011
    Report Date
    October 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: EXACT EVENT DATE IS UNKNOWN. DATE OF STUDY WAS USED. CITATION: ISABEL, L., KYLE, L., COME, T., DAVID, D.N., IMAN, S., DAVID, B., FELIX, C., AHMED, S. Z., NAEEM, BL, KEVIN, C. Z., FRANCK, B., LUCA, C., GIOVANNI, F., CARLOS, V., TIAGO, J. B., EDGARDO, F. B., VINCENT, ML, DEAN, EL., MAXIMILIAN, R., HANNES C. (2022). GLOBAL EXPERIENCE AND PROGRESS IN GREENLIGHT XPS 180-WATT PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE. WORLD JOURNAL OF UROLOGY, 40, 1513-1522.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A STUDY WAS CONDUCTED TO EVALUATE CHANGES IN GLOBAL PERIOPERATIVE DATA OF GREENLIGHT-XPS 180-WATT PHOTO-SELECTIVE VAPORIZATION OF THE PROSTATE (GL-XPS) OF THE GLOBAL GREENLIGHT GROUP (GGG) DATABASE. THE STUDY CONSISTED OF 3441 MEN WHO UNDERWENT GL-XPS FOR SYMPTOMATIC BPH BETWEEN 2011 AND 2019 AT SEVEN HIGH VOLUME INTERNATIONAL CENTERS, OPERATED BY EIGHT GL XPS SURGEONS EQUALLY EXPERIENCED IN PERFORMING GL-XPS REGULARLY. GL-XPS WAS PERFORMED USING THE XPS-180 W SYSTEM AND MOXY LASER FIBER. DATA IN THE STUDY SHOWS THAT THERE WAS SIGNIFICANT REDUCTION IN INTRAOPERATIVE AND POSTOPERATIVE HIGH-GRADE ADVERSE EVENTS (AES) WHILE OPERATIVE TIME AND LASER TIME SHOWED A STATISTICALLY SIGNIFICANT INCREASE BUT STAYED HIGHLY EFFICIENT OVER THE YEARS OF SURGERY AND WITHIN THE PROSTATE PV GROUPS. PERIOPERATIVE AES SIGNIFICANTLY DECREASED OVER THE YEARS. OVERALL, POSTOPERATIVE AES WERE SIGNIFICANTLY REDUCED TO ALMOST HALF ACROSS THE TIME OF THE STUDY. MORE SPECIFICALLY, THE MOST COMMON LOW-GRADE AE SUCH AS LUTS, HEMATURIA, AND URINARY RETENTION WERE REDUCED SIGNIFICANTLY BETWEEN 2011 AND 2019. ALL OTHER DOCUMENTED COMPLICATIONS SUCH AS STROKE, CARDIAC ISCHEMIA OR ANGINA PECTORIS STAYED CONSTANT AT AN EXTREMELY LOW LEVEL WITH A TOTAL OF 12 CASES DURING THE PERIOD OF 2011 TO 2019. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889737 UNKNOWN POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION UNK-P-GREENLIGHT FIBER

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other