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

Model Number PCO8VP

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Tissue Damage (2104); No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had a previous umbilical hernia which was repaired with a mesh back in march.It was stated that the patient presented approximately 2 weeks ago with another umbilical hernia, however the surgeon did not think it was a recurrence as the ultrasound showed it was a new hernia located above the outer edge of where the original mesh was placed.It was while they were doing the finger dissection to make space for a second ventral patch that they discovered that the bowel had adhered to the original mesh.It was then that they decided to remove the mesh.Bowel had adhered to both sides of the mesh.They closed the defect, placed another product as a sublay, closed the rectus over that mesh with a suture, then added a second product as an onlay.It should be noted that the surgeon has now had 2 bowel adhesions to the mesh.This resulted to an extended surgical time to 30 minutes or more and incision extension to more than 1 inch.This also resulted to a tissue damage.

Manufacturer Narrative

Evaluation summary: one device was returned for investigation.A review of the device history record has been performed by and no failure 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 returned sample shows that the sample was placed in a biohazard bag and returned in a specimen container.The sample was contaminated by blood and flesh.The textile knitting pattern, the 4 flaps and mesh dimension were found as expected.The collagen film was totally missed.The pgla expanders were found uncomplete on almost the half of the mesh.A blue yarn is visible in the middle of the mesh.The reported condition was confirmed.The visual examination of the returned sample confirmed the previous picture analysis.The pgla expanders were found uncomplete due to the bowel adhesion.It should be noted that the patient had a previous umbilical hernia which was repaired with a pco8vp.The product ifu which accompanies each device states in chapter "possible complication" that ¿the possible complications associated with the use of parietex¿ composite ventral patch are those typically associated with surgically implantable materials: seroma, hematoma, mesh migration, rec urrence, infection, chronic pain, inflammation, visceral adhesion, allergic reactions to the components of the product, fistula formation¿.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.The reported incident is confirmed by the sample examination.Known complication procedure.If information is provided in the future, a supplemental report will be issued.

• 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: 8110268
• MDR Text Key: 128578840
• Report Number: 9615742-2018-02628
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521165724
• UDI-Public: 10884521165724
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCO8VP
• Device Catalogue Number: PCO8VP
• Device Lot Number: PRL0501X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98