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

Model Number	VTX1515MX3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Necrosis (1971); Peritonitis (2252); Post Operative Wound Infection (2446); Bowel Perforation (2668); Unspecified Tissue Injury (4559)
Date of Event	06/28/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, it was noted the patient had previously undergone colectomy and ileus operation twice by surgery for intestinal perforation done by ileostomy.When closing the abdominal wall after vacuum-assisted closure (vac) and also 4 days after there was iatrogenic intestinal perforation with diffuse peritonitis, stomi, the monofilament mesh for reinforcement of the fascia was applied and suture was used.There was chronic wound infection that reappeared, which despite repeated antibiotic cures, vac and more reoperations did not rehabilitate.The patient was increasingly weakened and medical complications included death.
Event or Problem Description
According to the reporter, it was noted the patient had previously undergone colectomy and ileus operation twice by surgery for intestinal perforation done by ileostomy.When closing the abdominal wall after vacuum-assisted closure (vac) and also 4 days after there was iatrogenic intestinal perforation with diffuse peritonitis, stomi, the monofilament mesh for reinforcement of the fascia was applied and suture was used.There was chronic wound infection that reappeared, which despite repeated antibiotic cures in the abdominal wall and mesh, vac and more reoperations did not rehabilitate.The patient was increasingly weakened and medical complications included death due to respiratory acidosis, infection in abdomen related to illness.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSATEX
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13757432
• Report Number: 9615742-2022-00184
• Device Sequence Number: 17587452
• Product Code: FTL
• UDI-Device Identifier: 10884521532649
• UDI-Public: 10884521532649
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: VTX1515MX3
• Device Catalogue Number: VTX1515MX3
• Device Lot Number: SVA0123X200
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/08/2022
• 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: Death; Required Intervention
• Patient Sex: Female