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

Model Number	SYM3020F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
According to the reporter: the patient underwent a laparoscopic inguinal hernia repair.Post-operatively, the visceral side of the mesh was so intertwined and the parietal side practically without adhesions and did not hold.This event led the patient to undergo second surgery for incarcerated recurrence approximately 6 weeks post op.Patient is alive.
Additional Manufacturer Narrative
Evaluation summary: an evaluation was performed on the device.No product and no video were provided for evaluation.The visual examination of the provided picture shows that: the mesh was contaminated by blood, cut irregularly at several locations and the tissue integration was not uniform.The green marking is visible through the white textile.Neither pre-placed sutures nor fixation systems are visible.Many adhesions are observed on the film side of the mesh.Without the sample a detailed investigation could not be performed.Conclusion of the visual examination: the root cause could not be determined.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an investigation into the reported failure of symbotex composite mesh (sym).No product and no video were provided for evaluation.The visual examination of the provided picture shows that: the mesh was contaminated by blood, cut irregularly at several locations and the tissue integration was not uniform.The green marking is visible through the white textile.Neither pre-placed sutures (provided with (b)(4)) nor fixation systems are visible.Many adhesions are observed on the film side of the mesh.Without a physical product sample, we are unable to perform any functional or visual testing.The reported adhesion is a known potential complication of this type of surgery; this is a procedural related complication that is not normally attributed to any product/process deficiencies.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.Potential events associated with state of the art mesh with similar indication may include: organ injury (including bowel and visceral injury), trocar-site herniation, bowel obstruction and urinary retention (related with the use of anesthetics).¿ a review of the device history record indicated that the device was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 6868735
• Report Number: 9615742-2017-05244
• Device Sequence Number: 1182140
• Product Code: FTL
• UDI-Device Identifier: 10884521190528
• UDI-Public: 10884521190528
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: SYM3020F
• Device Catalogue Number: SYM3020F
• Device Lot Number: PPL0342X
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 10/12/2017; 02/14/2018
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/10/2017; 03/13/2018
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 105