BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REINFORCED RELOAD

    MDR report key: 19262498 · Received May 7, 2024

    Report

    Report Number
    1219930-2024-01990
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    December 27, 2023
    Report Date
    July 23, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D1, D4 (MODEL#, CATALOG#) ADDITIONAL INFORMATION: G3 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

    LARS KOLLMANN, MAXIMILIAN GRUBER, JOHAN F. LOCK, CHRISTOPH-THOMAS GERMER, FLORIAN SEYFRIED. CLINICAL MANAGEMENT OF MAJOR POSTOPERATIVE BLEEDING AFTER BARIATRIC SURGERY. OBESITY SURGERY (2024) 34. HTTPS://DOI.ORG/10.1007/S11695-023-07040-0. PAGES 751¿759 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 POSTOPERATIVE BLEEDING IN PATIENTS WHO UNDERWENT BARIATRIC SURGERY BETWEEN 2012 AND 2022. THERE WERE 1017 PATIENTS, OF WHOM 667 UNDERWENT GASTRIC BYPASS, AND 350 UNDER SLEEVE GASTRECTOMY. ALL SLEEVE GASTRECTOMIES WERE STAPLED USING A 60-MM PURPLE LINEAR ENDOSCOPIC STAPLING RELOADS WITH REINFORCED RELOADS USED AT THE SUBCARDIAL/PROXIMAL PART. A COMPETITOR DEVICE WAS USED IN GASTRIC BYPASS PROCEDURES. MAJOR POSTOPERATIVE INTRAABDOMINAL BLEEDING OCCURRED IN 8 SLEEVE GASTRECTOMY PATIENTS AND INTERVENTIONS INCLUDED BLOOD TRANSFUSIONS, ENDOSCOPY INTERVENTION AND REOPERATIONS. BLEEDING FROM THE STAPLE LINE WAS IDENTIFIED IN 3 OF 6 PATIENTS WHO UNDERWENT REOPERATION. ONE PATIENT DEVELOPED INTERMITTENT MULTIORGAN FAILURE DUE TO HEMORRHAGIC SHOCK FOLLOWED BY FULL RECOVERY. EXTENDED HOSPITAL STAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388482 UNKNOWN REINFORCED RELOAD STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN REINFORCED RELOAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| O