MAUDE Adverse Event Report: GUNZE LIMITED NEOVEIL SHEET; MESH, SURGICAL, ABSORBABLE, STAPLE LINE REINFORCEMENT

Model Number	NV-L-015G
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
On april 8, gunze learned that the patient was readmitted due to a cerebral infarction, not a myocardial infarction as previously reported.
Event or Problem Description
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 cerebral 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.

• 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
• Manufacturer (Section G): GUNZE LIMITED; 46, natsumegaichi, aono; ayabe, kyoto 623-8 513; JA 623-8513
• Manufacturer Contact: hidetoshi arimura ; tokyo shiodome building 15f; 1-9-1 higashishimbashi; minato-ku, tokyo 105-7-315 ; JA 105-7315
• MDR Report Key: 21732208
• Report Number: 3010668881-2025-00001
• Device Sequence Number: 18326770
• Product Code: OXC
• UDI-Device Identifier: 04548366322481
• UDI-Public: 04548366322481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown