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

Model Number	VTX5050M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter the patient experience a recurrent incisional hernia.The location of the hernia is midline.The patient will require repair, there will be an additional operation to correct the issue.The current patient status is alive with injury.The mesh implant procedure (approx.9 months previous) was an open repair of recurrent ventral incisional hernia, abdominal wall reconstruction, bilateral posterior transverse abdominus release and mayofascial medial advancement flaps.The size of the defect was 30cm x 27cm.The mesh was not cut prior to implantation.The mesh was not implanted in a contaminated field.The mesh was fixated by suture, the wound was closed by suture after the procedure.Mesh tore in patient post operation.Patient is scheduled for a repair of this recurrence on (b)(6) 2017.Pictures are available and will be provided.Patient medical history: previous bypass surgery, hernia repairs, allergies fish and iodine.
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
Evaluation summary: post market vigilance (pmv) led an evaluation of one image depicting a ct scan of an abdomen where the device was implanted.No product and no picture were provided for evaluation.A ct scan video was provided.Without the sample a detailed investigation could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures; additionally, a review of the device history records has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications.The root cause of the observed condition could not be reliably determined.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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
• MDR Report Key: 6694548
• Report Number: 9615742-2017-05180
• Device Sequence Number: 1718544
• Product Code: FTL
• UDI-Device Identifier: 10884521532298
• UDI-Public: 10884521532298
• Combination Product (Y/N): N
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2017

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 Expiration Date: 09/30/2020
• Device Model Number: VTX5050M
• Device Catalogue Number: VTX5050M
• Device Lot Number: SPJ0706X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 11/01/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 09/07/2017; 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 109