MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO15FX

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post operatively, on a laparoscopic umbilical hernia, upon implantation, the mesh was folded at the expanders junction on fascial side against fascial side, and the violet expanders were broken.The wound was closed after the procedure by suturing and there were twenty six fixation points applied.The surgical time was extended by thirty minutes or more due to the product problem and re operation was needed.The incision was extended more than 1 inch.The event lead to or extended the patient's hospitalization for five days.

Manufacturer Narrative

Evaluation summary a review of the device history record (dhr) has been performed by quality assurance.No failure or ncr that may relate to the reported conditions have been noted.Especially the records related to the collagen casting and the collagen based film results were found within specifications.The visual examination of the provided sample shows that the sample was not returned in its original packaging but placed in a box.The mesh was found contaminated by blood and a piece of flesh was found in the middle of the mesh.Mesh dimension and textile knitting were found as expected.25 tacks are visible and well placed and fixed all over the mesh.2 blue yarns were found on 2 edges of the mesh.The overhang of the collagen film was not present.The mesh was found wet and the collagen film seems to be completely resorbed.The reported condition was confirmed by the piece of flesh present in the middle of the mesh.The reported inflammation, pain and adhesion were known potential complications of this type of surgery.The product instructions for use (ifu) which accompanies each device states in chapter ¿possible complications¿ that ¿the possible complications associated with the use of device optimized composite mesh are those typically associated with surgically implantable materials: seroma/ hematoma / recurrence /adhesions/ chronic pains/ infection / fistula formation/ irritation/ inflammation/ allergic reactions to the components of the product.¿ a search of our global complaints database revealed that this was the only report on file for this lot of product.The review of historical data indicates that 3 cases coded as "mesh difficult to adhere" were reported.The report has been added to our product complaints database which is monitored for similar occurrences.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.No immediate action required.The reported condition was confirmed but did not occur at the production facilities.The reported conditions are known complication of the procedure.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post operatively, following a laparoscopic intraperitoneal onlay mesh (ipom) procedure for an umbilical hernia, upon implantation, the mesh was folded at the expanders junction on fascial side against fascial side, and the violet expanders were broken.The mesh was explanted due to inflammation and adhesion and the patient was having post operative complications such as pain and coming ileus.The wound was closed after the procedure by suturing and there were twenty six fixation points applied.The surgical time was extended by thirty minutes or more due to the product problem and re operation was needed.The incision was extended more than 1 inch.The event lead to or extended the patient's hospitalization for five days.The surgical time was extended by thirty minutes or more due to the product problem and re-operation was needed.The device was explanted 3 days following implantation.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7577849
• MDR Text Key: 110349393
• Report Number: 9615742-2018-01240
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179783
• UDI-Public: 10884521179783
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: PCO15FX
• Device Catalogue Number: PCO15FX
• Device Lot Number: PSC0176X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 81