MAUDE Adverse Event Report: GUNZE LIMITED NEOVEIL SHEET; Mesh, surgical, absorbable, staple line reinforcement

Model Number	NV-L-015G
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr report #: 3010668881-2025-00001 neoveil (sheet) was used to prevent pancreatic fluid leakage during a lymph node dissection performed as part of a gastrectomy for advanced gastric cancer on (b)(6) 2024.Postoperatively, there was no pancreatic leakage, and the patient was discharged soon thereafter.Approximately six months after discharge (b)(6) 2025), the patient was brought in for a myocardial infarction.A ct scan revealed a mass-like lesion in the area where the lymph node dissection had been performed.The lesion was surgically removed and sent for pathological examination.The final report suggested that the tissue was granulation tissue derived from neoveil (sheet) and had become extremely firm - likely scar tissue, according to the attending physician.Correction made on june 3 after a communication by the manufacturer that after discharge, the patient was admitted to the hospital for a "cerebral infarction" not a myocardial infarction as initially reported.

• Brand Name: NEOVEIL SHEET
• Common Device Name: Mesh, surgical, absorbable, staple line reinforcement
• Manufacturer (Section D): GUNZE LIMITED; 46 natsumegaichi, aono; ayabe; kyoto, 623-8 513; JA 623-8513
• MDR Report Key: 22131254
• Report Number: 3012602431-2025-00049
• Device Sequence Number: 15289439
• Product Code: OXC
• UDI-Device Identifier: 04548366322481
• UDI-Public: 04548366322481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2025
• Report Date (Section F): 04/09/2025

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 Model Number: NV-L-015G
• Device Lot Number: 24032001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/09/2025