BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 22870435 · Received August 22, 2025

    Report

    Report Number
    1219930-2025-03664
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    May 23, 2025
    Report Date
    August 22, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRIANTAFYLLOU, A.; MELA, E.; THEODOROPOULOS, C.; THEODOROU, A.P.; KITSOU, E.; SALIARIS, K.; KATSILA, S.; KAKOUNIS, K.; TRIANTAFYLLOU, T.; THEODOROU, D. ADDRESSING ANASTOMOTIC LEAK AFTER ESOPHAGECTOMY: INSIGHTS FROM A SPECIALIZED UNIT. J. CLIN. MED. 2025, 14, 3694. HTTPS://DOI.ORG/10.3390/ JCM14113694. 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 EVALUATED THE MANAGEMENT OF ANASTOMOTIC LEAK IN PATIENTS WHO UNDERWENT ESOPHAGECTOMY BETWEEN MARCH 2019 AND MARCH 2025. A BARBED SUTURE WAS USED TO HAND-SEW THE DEFECT FOLLOWING A STAPLED INTRATHORACIC ANASTOMOSIS UNTIL 2023. BETWEEN 2023 AND 2025, THE BARBED SUTURE WAS USED TO PERFORM TOTALLY HAND-SEWN, TWO-LAYER, END-TO-SIDE INTRATHORACIC ANASTOMOSIS. BEGINNING IN 2025, A COMPETITOR SUTURE WAS USED TO PERFORM THE INTRATHORACIC ANASTOMOSIS. A COMPETITOR SUTURE WAS USED TO PERFORM THE CERVICAL ANASTOMOSIS. THERE WERE 241 ESOPHAGEAL RESECTIONS PERFORMED WITH INTRATHORACIC ANASTOMOTIC LEAK OCCURRING IN 14 PATIENTS. DIAGNOSIS WAS CONFIRMED WITH COMPUTED TOMOGRAPHY SCAN OR ENDOSCOPY. TREATMENT INCLUDED INTRAVENOUS ANTIBIOTIC THERAPY, ENDOSCOPIC STENT PLACEMENT, DRAINAGE UNDER RADIOLOGIC GUIDANCE, ENDOSCOPIC VACUUM THERAPY, AND REOPERATION. ONE PATIENT DEVELOPED A TRACHEOESOPHAGEAL FISTULA FOLLOWING ENDOSCOPIC STENT PLACEMENT. PROLONGED HOSPITAL STAY AND READMISSIONS WERE REPORTED, INCLUDING ONE INTENSIVE CARE UNIT (ICU) READMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189866 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN SURGICAL UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R| H