BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 21113050 · Received January 9, 2025

    Report

    Report Number
    2647580-2025-00145
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    August 4, 2024
    Report Date
    January 9, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN EEA, UNKNOWN EEA (LOT#UNKNOWN); UNKNOWN EEA, UNKNOWN EEA (LOT#UNKNOWN); UNKNOWN EEA, UNKNOWN EEA (LOT#UNKNOWN); UNKNOWN EEA, UNKNOWN EEA (LOT#UNKNOWN); UNKNOWN EEA, UNKNOWN EEA (LOT#UNKNOWN) RISK FACTORS FOR AND TREATMENT OF ANASTOMOTIC STRICTURES AFTER IVOR LEWIS ESOPHAGECTOMY / SOPHIE L. F. DORAN, MARIA G. DIGBY, SOPHIE V. GREEN, CLIVE J. KELTY, ANAND P. TAMHANKAR, / SURGICAL ENDOSCOPY (2024) 38:6771¿6777 / HTTPS://DOI.ORG/10.1007/S00464-024-11150-W / PUBLISHED ONLINE: 19 AUGUST 2024 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. 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 ASSESS THE RATE OF AND RISK FACTORS FOR ANASTOMOTIC STRICTURE IN 207 PATIENTS WHO UNDERWENT IVOR LEWIS ESOPHAGECTOMY FOR ESOPHAGEAL CANCER BETWEEN 2013 AND 2021. A STANDARD CIRCULAR STAPLED END-TO-SIDE ESOPHAGO-GASTRIC ANASTOMOSIS WAS PERFORMED USING A 25 MILLIMETER (MM) CIRCULAR STAPLER. POST OPERATIVE COMPLICATIONS INCLUDED ANASTOMOTIC LEAK AND ANASTOMOTIC STRICTURE IN 12 PATIENTS. ANASTOMOTIC STRICTURES REQUIRED RADIATION EXPOSURE DURING A SWALLOW STUDY AND ONCE OR MORE THAN ONE ENDOSCOPIC BALLOON DILATATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325310 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention PLEASE SEE NOTE ON H11.