BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 21028011 · Received December 27, 2024

    Report

    Report Number
    1219930-2024-05928
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    August 31, 2024
    Report Date
    December 27, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPARATIVE ANATOMIC AND SYMPTOMATIC RECURRENCE OUTCOMES OF DIAPHRAGMATIC SUTURE CRUROPLASTY VERSUS BIOSYNTHETIC MESH REINFORCEMENT IN ROBOTIC HIATAL AND PARAESOPHAGEAL HERNIA REPAIR / NILOUFAR SALEH / SURGICAL ENDOSCOPY (2024) 38:6476¿6484 / PUBLISHED ONLINE: 13 SEPTEMBER 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 COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT ROBOTIC REPAIR OF HIATAL AND PARAESOPHAGEAL HERNIAS WITH SUTURE CRUROPLASTY WITH OR WITHOUT BIOSYNTHETIC MESH REINFORCEMENT BETWEEN JANUARY 2012 AND APRIL 2024. IT WAS NOTED THAT CLOSURE OF THE HIATAL OPENING WAS ACCOMPLISHED WITH A 3-0 V LOC RUNNING SUTURE AND REINFORCED WITH A COMPETITOR SUTURE. THERE WERE 503 PATIENTS INCLUDED IN THE STUDY; 308 UNDERWENT MESH REPAIR, AND 195 UNDERWENT SUTURE-ONLY REPAIR. HERNIA REOCCURRENCE WAS NOTED IN 84 PATIENTS. 19 IN THE MESH GROUP AND 8 IN THE SUTURE GROUP EXPERIENCED ANATOMIC RECURRENCE IN THE SHORT-TERM FOLLOW-UP. IN THE LONG-TERM FOLLOW-UP, 29 IN THE MESH GROUP AND 28 IN THE SUTURE GROUP EXPERIENCED ANATOMIC RECURRENCE. INTERVENTIONS AND PATIENT OUTCOMES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513267 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other