MAUDE Adverse Event Report: AROA BIOSURGERY 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
Event or Problem Description
A patient underwent a complex bridged robotic ventral ipom (intraperitoneal onlay mesh) hernia repair with ovitex 1s permanent on approximately on (b)(6) 2024.The patient returned with adhesions and a bowel obstruction on approximately on (b)(6) 2024 and the device was explanted.
Additional Manufacturer Narrative
Adhesions are common events after abdominal surgery.Extent and strength of adhesions may differ based on the procedure performed and underlying patient conditions and may lead to bowel obstruction.It was reported that adhesions were difficult to take down but no bowel resection was required to address the obstruction.The surgeon noted that he utilizes a large number of tacks for surgical mesh placement and it is possible that these contributed to the adhesions and noted bowel obstruction as well.It should be noted that dates of implant and explant are approximate based on the information received from the surgeon.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 19353852
• Report Number: 3010513348-2024-00011
• Device Sequence Number: 7689059
• Product Code: FTM
• UDI-Device Identifier: 09421904065727
• UDI-Public: 09421904065727
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2024
• Report Date (Section F): 05/20/2024

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/22/2024
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/20/2024