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

Model Number	VTX5050M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hernia (2240); Prolapse (2475); No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operative a robotic laparoscopic abdominal wall reconstruction procedure, a portion of the mesh along with patient tissue was explanted during repair of recurrent hernia.The mesh fractured was repaired to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with qa specifications for all product lots prior release to market.The visual examination of the provided sample shows that the sample was not returned in its original packaging and the part of the mesh returned was found completely adhered with human flesh.The sample returned was unfeasible.It was not possible to investigate more.The investigation concluded that the reported condition could not be confirmed.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the sample was not returned in its original packaging, and the part of the mesh was found completely adhered with human flesh.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that the mesh was torn.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
Additional Manufacturer Narrative
H6 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.
Event or Problem Description
According to the reporter, post operatively, on a robotic laparoscopic abdominal wall reconstruction procedure, a portion of the mesh along with the patient tissue was explanted during repair of recurrent hernia.The mesh fractured was repaired to complete the case.

• 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: justin ellis ; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 7685141
• Report Number: 9615742-2018-01563
• Device Sequence Number: 13781872
• Product Code: FTL
• UDI-Device Identifier: 10884521532298
• UDI-Public: 10884521532298
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/18/2022

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: VTX5050M
• Device Catalogue Number: VTX5050M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/12/2018; 07/08/2022; 08/17/2022
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/02/2018; 11/09/2018; 07/26/2022; 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Sex: Unknown