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

Model Number	VTX1510
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during a tapp procedure, the doctor tried to nail the product with a tacker, holes of mesh extended and the tacks got through the mesh.A big hole on the center was created by the doctor to check the strength of the mesh.The operating time was extended more than 30 minutes.There was tissue damage.There was oozing bleeding.The procedure was completed with another device.The status of the patient: no problem.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance led an evaluation of one device.The visual examination of the returned sample shows that the sample was not returned in its original packaging.The mesh was not contaminated by blood.The dimensions of the mesh were found as expected even if the mesh was cut on each side by the user.3 holes are visible the biggest is 3 cm by 3 cm.The textile at the hole location was found overstretched.The mesh seems to have been tear by the user both others are 1 cm by 1 cm and 0,5 by 0,5 cm.The textile was found cut and overstretched for both holes.A review of the device history record, has been performed no failure or ncr that may relate to the reported conditions have been noted.Especially the review of qc records related to the mechanical testing of the textile batches used for this lot confirms compliance to qa specifications.We can note that the surgeon indicates having created the hole to check the strength of the mesh which confirm the visual examination.Excessive manipulation by the user is highly suspected.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 device.The visual examination of the returned sample shows that: the sample was not returned in its original packaging: only the commercial box and the tyvek pouch.The mesh was not contaminated by blood.The dimensions of the mesh were found as expected even if the mesh was cut on each side by the user.The textile was found cut and overstretched for both holes.We can note that the surgeon indicates having created the hole to check the strength of the mesh which confirm the visual examination.The root cause of the observed condition is excessive manipulation by the user.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: 6983032
• Report Number: 9615742-2017-05573
• Device Sequence Number: 16273106
• Product Code: FTL
• UDI-Device Identifier: 10884521532229
• UDI-Public: 10884521532229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2018

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: 02/28/2020
• Device Model Number: VTX1510
• Device Catalogue Number: VTX1510
• Device Lot Number: SPC1063X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 05/04/2018
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/08/2017; 06/01/2018
• 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