BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 20565417 · Received October 30, 2024

    Report

    Report Number
    1219930-2024-05109
    Event Type
    Death
    Date Received
    October 30, 2024
    Date of Event
    June 30, 2024
    Report Date
    January 20, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#UNKNOWN); UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#UNKNOWN); UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#UNKNOWN) REFERENCES: DONG WANG, SURGICAL ENDOSCOPY (2024) THE LEARNING CURVE OF LAPAROSCOPIC SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION FOR PORTAL HYPERTENSION WITH 10-YEAR FOLLOW-UP; 38:5228¿5238 HTTPS://DOI.ORG/10.1007/S00464-024-11017-0 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

    MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT ONE IMAGE OF A TISSUE CAVITY. AN UNIDENTIFIED RELOAD COULD BE SEEN CLAMPED ONTO TISSUE. THE RELOAD STAPLE CARTRIDGE APPEARED TAN OR GRAY BUT COULD NOT BE CONFIRMED DUE TO IMAGE QUALITY. A CLIP COULD BE SEEN APPLIED TO TISSUE. THE RELOAD COULD NOT BE IDENTIFIED. IT WAS REPORTED THAT THERE WAS MEDICAL COMPLICATION REPORTED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 LITERATURE SOURCE OF THE RETROSPECTIVE STUDY PERFORMED FROM JANUARY 2005 TO NOVEMBER 2020 TO 594 PORTAL HYPERTENSION (PHT) PATIENTS WITH LIVER CIRRHOSIS WHO UNDERWENT EITHER OPEN SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION (OSED)OR LAPAROSCOPIC SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION (LSED). THERE WERE 236 PATIENTS WHO UNDERWENT OPEN SURGERY, AND 358 UNDERWENT LAPAROSCOPIC SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION (LSED). IN THE LAPAROSCOPIC SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION (LSED) GROUP, THE COMPANY'S DEVICES WERE UTILIZED FOR VESSEL DISRUPTION. THE COMPANY'S STAPLER WAS USED TO TRANSECT THE SPLENIC HILUM AND THE ROOT OF THE LEFT GASTRIC VEIN. IN TRADITIONAL OPEN SURGERY, SURGICAL TECHNIQUES INCLUDING CLAMP, TRANSECTION, LIGATION, AND SUTURE WERE PERFORMED IN A CONVENTIONAL WAY. COMPLICATIONS IN THE LAPAROSCOPIC SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION (LSED) GROUP INCLUDED BLEEDING. CONVERSION TO OPEN SURGERY WAS REPORTED DUE TO INTRAOPERATIVE BLEEDING. ENDOSCOPIC TREATMENT AND ADDITIONAL SURGERY WERE REQUIRED TO TREAT POSTOPERATIVE BLEEDING. TWO PATIENTS NEEDED INTENSIVE CARE UNIT (ICU) MANAGEMENT DUE TO HYPOTENSION AND SHOCK. ONE PATIENT DIED OF INTRA-ABDOMINAL BLEEDING POST-DISCHARGE WITHIN 1 MONTH. TRANSFUSIONS WERE ALSO REPORTED. BLEEDING WAS IDENTIFIED IN THE RETROPERITONEUM POSTERIOR TO THE SPLEEN OR AT THE ROOT OF THE LEFT GASTRIC VEIN. BLEEDING IS INHERENT TO THE PROCEDURE DUE TO PORTAL HYPERTENSION, MASSIVE SPLENOMEGALY AND GASTROESOPHAGEAL VARICOSE VEINS. DUE TO COMPROMISED LIVER FUNCTION AND UNRESTORED PLATELET FUNCTION AND QUANTITY, PATIENTS WITH PORTAL HYPERTENSION (PHT) ARE MORE SUSCEPTIBLE TO POSTOPERATIVE BLEEDING THAN OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042078 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R| D