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

Catalog Number	F10246-1020P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During removal, a biopsy from the fascia at the edge of the fistula was taken which confirmed that the repair was intact with the ovitex implant remodeled.Although the polymeric portion of the device was removed, the implant still performed its primary function of soft tissue reinforcement.The patient is doing well as of (b)(6) 2019.Further, a dhr review was completed and no non-conformances or anomalies were found that may have caused or contributed to this event.(b)(4).
Event or Problem Description
On (b)(6) 2018, a patient with a history of diverticulosis and a right hemi-colectomy underwent a robotic laparoscopic incisional repair of an incisional hernia in the midline.Primary closure was obtained and reinforced with intraperitoneal placement of ovitex 1s permanent 16x20cm.The mesh was cut into two equal pieces and sewn together (approximately 10x30cm).In late (b)(6) 2019, the patient presented with swelling and pain of the anterior abdominal wall.A ct revealed free air in the subcutaneous tissue.The proximal and distal ends of the wound were opened and copious amount of fecal matter was evacuated, and with it a portion of the polymer reinforcement of the mesh.Upon further inspection the surgeon found an enteric fistula that communicated with the subcutaneous space.The subcutaneous space was lavaged and inspected.Except for the fistula, the fascia and hernia repair appeared intact.Antibiotics were started and subsequently the fistula was first ligated and then removed.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 8459986
• Report Number: 3007321028-2019-00002
• Device Sequence Number: 3014098
• Product Code: FTM
• UDI-Device Identifier: 09421904065109
• UDI-Public: 09421904065109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2019
• Report Date (Section F): 03/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: F10246-1020P
• Device Lot Number: ERT-8A04
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/26/2019
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/28/2019
• 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: Hospitalization; Other