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); Unspecified Tissue Injury (4559)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to reporter when the patient fell off an exam table at another doctors office they felt a pop, resulting in recurrence.The recurrence was later fixed robotically.The issue was post op, resulting in another repair of the recurrence.The original surgical procedure was an open repair of ventral incisional hernia and abdominal wall reconstruction and cholecystectomy.The size of the defect was 21m x 30cm.The location of the hernia is midline.The fixation system used was suture.The mesh was cut prior to implantation.The appearance of the mesh was normal.The patent outcome is alive - no injury.
Additional Manufacturer Narrative
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
Medtronic complaint number: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Per additional information received the defect was repaired robotically, tear in mesh was closed with prolene suture.The mesh was not removed.No mesh was used due to gallbladder removal at same time.
Additional Manufacturer Narrative
Correction: a5a, a5b, b2(removed other), b5, b7, d4(expiration date, udi), d8, e1(street 1), g1, g4, h4, 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 reporter, when the patient fell off an exam table at another doctors office the user felt a pop, resulting in recurrence, which was later fixed robotically.The tear in the mesh was closed with a suture.No mesh was used due to the gallbladder removal at same time.The mesh was not removed.The issue was post operative, resulting in another repair of the recurrence.The original surgical procedure was an open repair of ventral incisional hernia and abdominal wall reconstruction and cholecystectomy.The size of the defect was 21m x 30cm.The location of the hernia was midline.The fixation system used was suture.The mesh was cut prior to implantation.The mesh dimensions after cutting was 45x40cm.The appearance of the mesh was normal.

• 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, CT 80301 ; 3035816943
• MDR Report Key: 6649870
• Report Number: 9615742-2017-05163
• Device Sequence Number: 1191086
• 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 Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/25/2022

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 Expiration Date: 10/31/2020
• Device Model Number: VTX5050M
• Device Catalogue Number: VTX5050M
• Device Lot Number: SPJ1016X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 06/13/2017; 07/08/2022
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 07/12/2017; 09/07/2017; 07/25/2022
• Date Device Manufactured: 11/19/2015
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 125 KG