BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 24222958 · Received January 30, 2026

    Report

    Report Number
    1219930-2026-00594
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    September 22, 2025
    Report Date
    February 12, 2026
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEGMENTAL RESECTION OF THE INFERIOR VENA CAVA IS SAFE AND FEASIBLE FOR PATIENTS WITH RENAL CELL CARCINOMA WITH TUMOR THROMBUS: A LARGE-SCALE RETROSPECTIVE STUDY FROM A HIGH-VOLUME CENTER LE YU, MD, WEILIANG ZHANG, MD, PEICHEN DUAN, MD, FAN ZHANG, MD, SHAOHUI DENG, MD, YE YAN, MD, ZHOU LIU, MD, YIMENG SONG, PHD, GUOLIANG WANG, MD, HONGXIAN ZHANG,MD, PENG HONG, MD , AND SHUDONG ZHANG, MD ANN SURG ONCOL (2026) 33:824¿831; DOI.ORG/10.1245/S10434-025-18345-Y MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDED H6 (IME) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY AIMED TO EVALUATE PERIOPERATIVE OUTCOMES OF INFERIOR VENA CAVA SEGMENTAL RESECTION IN RENAL CELL CARCINOMA WITH TUMOR THROMBUS. THE STUDY INCLUDED 271 PATIENTS UNDERGOING RADICAL NEPHRECTOMY FROM (B)(6) 2020 TO (B)(6) 2024. BLOOD TRANSFUSIONS WERE NOTED IN 90 PATIENTS INTRAOPERATIVELY. THERE WERE 63 PATIENTS THAT EXPERIENCED POSTOPERATIVE COMPLICATIONS OF ALL GRADES, INCLUDING 8 PATIENTS WITH CLAVIEN-DINDO GRADE III (SERIOUS INJURY) OR HIGHER; HOWEVER, THERE IS NO FURTHER INFORMATION TO CLASSIFY THE CLINICAL SYMPTOMS/SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284519 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention