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

Model Number	F10246-1012G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Scar Tissue (2060); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
This follow-up report is to add additional information in d5, d8, and d9.
Event or Problem Description
A patient self-reported complications after hiatal hernia repair with a tif procedure in (b)(6) 2020 with ovitex 1sr.The patient reported experiencing dysphagia for approximatley 10 months and underwent addtional surgery (time unknown).The patient reported potential device embedment and scar tissue at the esophagus.
Event or Problem Description
A patient self-reported complications after hiatal hernia repair with a tif procedure on (b)(6) 2020 with ovitex 1sr.The patient reported experiencing dysphagia for approximately 18 months.The patient underwent multiple surgical and diagnostic procedures to attempt to address these symptoms.
Additional Manufacturer Narrative
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 on (b)(6) 2020 (10 months post-op) endoscopy, an extruded suture was removed but no extruded mesh was noted.On (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.

• 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: 15265324
• Report Number: 3010513348-2022-00004
• Device Sequence Number: 15103162
• Product Code: FTM
• UDI-Device Identifier: 09421904065307
• UDI-Public: 09421904065307
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2023
• Report Date (Section F): 02/21/2023

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: 07/31/2020
• Device Model Number: F10246-1012G
• Device Catalogue Number: F10246-1012G
• Device Lot Number: ERT-9B10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2022
• Device Age: 1 YR
• Date Report to Manufacturer: 02/21/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 08/22/2022; 02/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TIF PROCEDURE WITH SUTURE FASTENERS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/22/2022