BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EEA

    MDR report key: 21090246 · Received January 7, 2025

    Report

    Report Number
    2647580-2025-00096
    Event Type
    Death
    Date Received
    January 7, 2025
    Date of Event
    August 9, 2024
    Report Date
    January 7, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KEOUNA PATHER·HAYTHAM ALABBAS·CARLOS GONZALEZ-BAERGA·MANUEL MENENDEZ·MAYUR K. VIRARKAR·IRAI SANTANA DE OLIVEIRA· ERIN M. MOBLEY· ZIA D T. AWAD. "MAJOR CORONARY ARTERY CALCIFCATIONS AS PREDICTORS OF POSTOPERATIVE COMPLICATIONS IN IVOR LEWIS ESOPHAGECTOMIES: A FVE-YEAR RETROSPECTIVE ANALYSIS", 2024, SURGICAL ENDOSCOPY (2024) 38:6865¿6872 HTTPS://DOI.ORG/10.1007/S00464-024-11181-3. 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 WAS COMPLETED INVOLVING 100 CASES HAVING PREOPERATIVE ARTERIAL CALCIFICATIONS THAT UNDERWENT MINIMALLY INVASIVE IVOR LEWIS ESOPHAGECTOMIES FROM 2013 TO 2018. AN UNKNOWN LAPAROSCOPIC LINEAR STAPLER WAS USED TO CREATE A GASTRIC CONDUIT. THE 25 MM DST XL CIRCULAR STAPLER WAS USED TO CREATE END-SIDE ESOPHAGOGASTRIC ANASTOMOSIS. POSTOPERATIVE COMPLICATIONS INCLUDE ANASTOMOTIC LEAK, GRAFT/CONDUIT NECROSIS, AND CONDUIT OBSTRUCTION. REOPERATION WAS REQUIRED FOR CONDUIT OBSTRUCTION/NECROSIS. NO REOPERATION WAS REPORTED FOR ANASTOMOTIC LEAK. READMISSIONS WERE ALSO REPORTED. OTHER COMPLICATIONS UNRELATED TO THE DEVICE INCLUDE ATRIAL FIBRILLATION, RESPIRATORY FAILURE, PLEURAL EFFUSIONS, COLONIC PSEUDO-OBSTRUCTION, CONDUIT VOLVULUS, CONDUIT REDUNDANCY, CECAL VOLVULUS, TOXIC MEGACOLON, CLOSED-LOOP OBSTRUCTION, WOUND INFECTION, AND LUNG DECORTICATION. DEATH OCCURRED IN FOUR CASES DUE TO UNSPECIFIED REASONS. TITLE: MAJOR CORONARY ARTERY CALCIFICATIONS AS PREDICTORS OF POSTOPERATIVE COMPLICATIONS IN IVOR LEWIS ESOPHAGECTOMIES: A FVE-YEAR RETROSPECTIVE ANALYSIS. KEOUNA PATHER1 · HAYTHAM ALABBAS1,3 · CARLOS GONZALEZ-BAERGA2 · MANUEL MENENDEZ2 · MAYUR K. VIRARKAR2 · IRAI SANTANA DE OLIVEIRA2 · ERIN M. MOBLEY1 · ZIAD T. AWAD1 SURGICAL ENDOSCOPY (2024) 38:6865¿6872 HTTPS://DOI.ORG/10.1007/S00464-024-11181-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322008 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death