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

Model Number SYM20

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

Patient Problems Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); Reaction (2414); Fluid Discharge (2686); No Code Available (3191)

Event Date 11/08/2018

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, 3 days after laparoscopic recurrent ventral hernia repair, the patient was in an immense amount of pain.The patient's family called the surgeon and informed him that the patient had not taken any of the medication post operatively but was in a great deal of pain.The surgeon told the patient to take the medication and when the patient's status was checked, the patient was doing better but still in pain.The patient came to the hospital and did a computed tomography (ct) scan.Fluid in his stomach was seen and the patient was brought back to the operating room for an exploratory laparoscopic procedure.They started the procedure laparoscopic and noticed the area to be extremely red and the mesh had mild adhesions.At the time his white blood cell count was only 11 and so they did not believe he had an infection.They also noticed a fluid in the abdomen.Seroma and "fluid foul smelling discharge through drains" were also noted.The mesh was explanted and the surgeon was concerned that the patient might have an allergy to porcine, glycerol or polyester.Only known allergies of the patient were that he was allergic to antihistamines.Patient was morbidly obese and had 4 prior failed hernia repairs.The surgeon also noted that during the original procedure the patient had bowel incarcerated in the hernia but before closing checked all bowel to ensure there was no enterotomy that could have contributed to this.To resolve the issue, the surgeon did a primary repair of the defect and did not place mesh.The surgeon then converted from laparoscopic to open and examined the bowel for close to two hours to ensure there was no enterotomy in the bowel causing patient pain and seromas.Patient hospitalization was extended since he had to return to the hospital and have the mesh removed.Tissue damage and an unanticipated tissue loss were also noted.

Manufacturer Narrative

Evaluation summary: a review of the device history record has been performed and no failure that may relate to the reported conditions have been noted.The visual examination of the provided picture shows: the mesh was contaminated by blood.Mesh dimension could not be checked by the visual examination.The textile knitting pattern and the visual central marker seems to be found as expected.The collagen film was found delaminated on a large part of the mesh.No trace of adhesion is visible on the mesh.An additional yarn is fixed on the central marker.12 absorbable tackers are visible around the mesh.The closest visible tacker is fixed at 3 stitches from the side.The reported condition relative to the collagen barrier was confirmed by this examination.The seroma incident reported could not be confirmed.The product ifu which accompanies each device states in chapter "possible complications" that " the possible complications associated with the use of symbotex¿ composite mesh are those typically associated with surgically implantable mesh: seroma, hematoma, recurrence, adhesions, fistula formation, infection, inflammation, chronic pain, and/or allergic reactions to the components of the product.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• 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: 8124051
• MDR Text Key: 129024569
• Report Number: 9615742-2018-02654
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521593435
• UDI-Public: 10884521593435
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: SYM20
• Device Catalogue Number: SYM20
• Device Lot Number: PQK0327X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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: 72 YR