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

Model Number	SYM3020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); High Blood Pressure/ Hypertension (1908); Necrosis (1971); Bowel Perforation (2668); Tissue Breakdown (2681)
Date of Event	05/10/2024
Type of Reportable Event	Death
Event or Problem Description
According to the reporter, during an open ventral hernia procedure on a patient due to hernia incarceration, mechanical ileus, and visceral attachments as result of previous medical condition, a mesh was used in ideal condition using the inlay technique and was fixated by sutures.However, three months later, the patient came to the hospital with hypertension, heart fibrillation, and with clinical picture of acute abdomen.The patient had tissue damage due to intestinal perforation.The surgeon performed extirpation of parts of the mesh, resection of small intestines, ileostomy with terminal ileofistula, and drainage.The patient died a day after the procedure.
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, during an open ventral hernia procedure on a patient due to hernia incarceration, mechanical ileus, and visceral attachments as result of previous medical condition, a mesh was used in ideal condition using the inlay technique and was fixated by sutures.However, three months later, the patient came to the hospital with hypertension, heart fibrillation, and with clinical picture of acute abdomen.The patient had tissue damage due to intestinal perforation.The surgeon performed extirpation of parts of the mesh, resection of small intestines, ileostomy with terminal ileofistula, and drainage.The reaction between the mesh and the bowel that the mesh had been adherent to, have caused the necrosis of the bowel and the perforation of the bowel.During the surgery, the mesh was excised, and it was not preserved.The patient was admitted to the intensive care unit post-operative.In the intensive care unit, the patient was on mechanical ventilation and inotropic support with other medications and infusional rehydration methods.The patient died the following day due to endogenous intoxication caused by perforation of the bowel and peritonitis and subsequent sepsis.
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.

• Brand Name: SYMBOTEX
• 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: 19490305
• Report Number: 9615742-2024-00811
• Device Sequence Number: 7089434
• Product Code: FTL
• UDI-Device Identifier: 10884521190511
• UDI-Public: 10884521190511
• Combination Product (Y/N): N
• PMA/510(K) Number: K142908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: SYM3020
• Device Catalogue Number: SYM3020
• Device Lot Number: PWI1459X
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/27/2024
• Date Device Manufactured: 09/29/2022
• 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: Hospitalization; Death; Required Intervention
• Patient Sex: Female