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

Model Number	SYM1510F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Discomfort (2330); No Code Available (3191)
Date of Event	02/13/2019
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, following seemingly successful laparoscopic ventral hernia repair with this mesh, the patient reported to have significant discomfort at the repair site.Diagnostic laparoscopy was performed and identified severe adhesions involving bowel stuck to the mesh.Additional operation was performed to correct the issue.Adhesions were successfully removed, mesh was left in place (it had remained exactly as positioned in initial repair) and an anti-adhesive product was applied to prevent further adhesions.
Additional Manufacturer Narrative
One device was returned for investigation.A review of the device history record could not be performed.All process and test criteria are verified as complying with qa specifications for all product lots prior release to market.The visual examination of the provided pictures (in vivo pictures) shows that: the photo shows a well-integrated mesh in vivo.The mesh seems to be partially covered.However due to the picture quality, it is not possible to determine the textile and the mesh dimension.6 photos in vivo seem to show the remaining of adhesion.On one photo the mesh is visible but due to the picture quality, it is not possible to determine the textile and the mesh dimension.The reported condition seems to be confirmed.The reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy.It should be noted that each collagen casting step and the collagen based film results are controlled prior release.A defect would have been detected and the product rejected.The reported adhesion is a known potential complication of t his 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 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).¿ based on the available information, 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 known complication procedure.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 8397195
• Report Number: 9615742-2019-00413
• Device Sequence Number: 1628185
• Product Code: FTL
• UDI-Device Identifier: 10884521190382
• UDI-Public: 10884521190382
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: SYM1510F
• Device Catalogue Number: SYM1510F
• Device Lot Number: PRL1003X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 04/25/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/01/2019; 05/19/2019
• 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