MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX REINFORCED TISSUE MATRIX; SURGICAL MESH

Model Number	F10246-2530P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aroa's review of manufacturing documentation for the subject lot (ert-22l18) has confirmed that the devices were produced in accordance with the established procedures, with all process and final release specifications satisfied.Adhesion and bowel obstruction are noted as potential complications in the instructions for use of the device.Extent and strength of adhesions may differ based on the procedure performed and underlying patient conditions and may lead to bowel obstruction.The surgeon indicated that he utilizes a large number of tacks for surgical mesh placement and it is possible that this contributed to the adhesions and bowel obstruction.The surgeon also noted that no bowel resection was required to address the obstruction.Dates of implant and explant are approximate based on the information received from the surgeon.
Event or Problem Description
A patient underwent a complex bridged robotic ventral ipom (intraperitoneal onlay mesh) hernia repair with ovitex 1s permanent on approximately (b)(6) 2024.The patient returned with adhesions and a bowel obstruction on approximately (b)(6) 2024 and the device was explanted.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer Contact: tina o'brien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 19367296
• Report Number: 3007321028-2024-00028
• Device Sequence Number: 3785093
• Product Code: FTM
• UDI-Device Identifier: 09421904065727
• UDI-Public: 09421904065727
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K181935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: F10246-2530P
• Device Catalogue Number: F10246-2530P
• Device Lot Number: ERT-22L18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown