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

Model Number VTX5050M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 05/12/2017

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6694548
• MDR Text Key: 79350640
• Report Number: 9615742-2017-05180
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521532298
• UDI-Public: 10884521532298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 06/13/2017; 11/01/2017
• Supplement Dates FDA Received: 09/07/2017; 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 109