BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX

    MDR report key: 15271915 · Received August 22, 2022

    Report

    Report Number
    3007321028-2022-00028
    Event Type
    Injury
    Date Received
    August 22, 2022
    Report Date
    August 23, 2022
    Manufacturer
    AROA BIOSURGERY LTD
    Product Code
    FTM
    UDI-DI
    09421904065307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INSUFFICIENT DEVICE INFORMATION RECEIVED TO CONDUCT INVESTIGATION OF MANUFACTURING RECORDS. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION UPDATE IS PROVIDED BELOW: UPON REVIEW OF MEDICAL RECORDS PROVIDED BY THE PATIENT, IT IS UNLIKELY THAT THE OVITEX DEVICE CAUSED OR CONTRIBUTED TO THE ISSUES NOTED IN THE ORIGINAL REPORT. THE PATIENT REPORTED A COMPLEX MEDICAL HISTORY PRIOR TO HERNIA REPAIR WITH OVITEX. THE INITIAL PROCEDURE WAS ALSO CONDUCTED TOGETHER WITH A TIF PROCEDURE THAT IMPLANTED MULTIPLE PERMANENT FASTENERS. MULTIPLE ENDOSCOPIES SHOWED NO INJURIES TO THE ESOPHAGUS AND THAT THE TIF VALVE WAS INTACT (4 AND 6 MONTHS AFTER INITIAL SURGERY, RESPECTIVELY). DURING A (B)(6) 2020 (10 MONTHS POST-OP) ENDOSCOPY, AN EXTRUDED SUTURE WAS REMOVED BUT NO EXTRUDED MESH WAS NOTED. IN (B)(6) 2021, (17 MONTHS AFTER INITIAL SURGERY) THE TIF WAS ATTEMPTED TO BE REVERSED. NO RECORDS ARE AVAILABLE AFTER THIS TIME. A BATCH RECORD REVIEW OF THE LOT UTILIZED IN THE ORIGINAL PROCEDURE SHOWED NO NON-CONFORMANCES OR ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ISSUE NOTED.

    Description of Event or Problem · 0

    A PATIENT SELF-REPORTED COMPLICATIONS AFTER HIATAL HERNIA REPAIR WITH A TIF PROCEDURE IN FEBRUARY 2020 WITH OVITEX 1SR. THE PATIENT REPORTED EXPERIENCING DYSPHAGIA FOR APPROXIMATELY 10 MONTHS AND UNDERWENT ADDITIONAL SURGERY (TIME UNKNOWN). THE PATIENT REPORTED POTENTIAL DEVICE EMBEDMENT AND SCAR TISSUE AT THE ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2771621 OVITEX OVITEX ABSORBABLE MESH FTM AROA BIOSURGERY LTD F10246-1012G ERT-9B10 09421904065307

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention TIF PROCEDURE WITH SUTURE FASTENERS