MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number	PCO2H4
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Abscess (1690); Perforation (2001); Hernia (2240); Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, in (b)(6) 2023 a laparoscopic esophageal hiatal hernia was performed.The mesh was placed after hernia orifice closure and had no issue.Two years later, the patient had recurrence accompanied by gastric mesh erosion, stomach perforation, abscess formation and right-side heart failure.It was noted that a second surgery is scheduled.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (ime e0611 removed) correction: d4 (unique identifier (udi) #).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, in april 2023 a laparoscopic esophageal hiatal hernia was performed.The mesh was placed after hernia orifice closure and had no issue.Two years later, the patient had recurrence accompanied by gastric mesh erosion, stomach perforation, abscess formation.Right-side heart failure recurrence was also noted, but does was not caused by the device.It was noted that a second surgery is scheduled.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22248093
• Report Number: 9615742-2025-00739
• Device Sequence Number: 13176592
• Product Code: FTL
• UDI-Device Identifier: 10884521178472
• UDI-Public: (01)10884521178472(17)270930(10)PWJ1216M(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PCO2H4
• Device Catalogue Number: PCO2H4
• Device Lot Number: PWJ1216M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 10/20/2022
• 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