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

Model Number	SYM15F
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, 23 days post-operatively of a laparoscopic abdominal wall hernia repair, the mesh had not fused with peritoneum.A part of tacking came off and was found hanging in the abdominal cavity.On the right side, the mesh was found to have a gap between the mesh and peritoneum.The thread for the plicated hernia orifice was also in the condition that had come off.Repair for the relapse was done.A small laparotomy with another mesh was performed to repair the relapse.
Additional Manufacturer Narrative
Evaluation summary: one device was returned for investigation.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 sample and pictures was performed in collaboration with the textile principal engineer and showed that the sample was not returned in its original packaging but placed in a plastic bag.The sample was found contaminated by blood and showed evidence of mold on the entire surface of the mesh (black traces) and next to the mrk (white traces).The mesh diameter was around 14 cm, the diameter for a sym15 is 15 cm.The textile knitting pattern (3ds and mrk) was found as expected.The collagen film did not cover all the pores of the mesh and was absent on the overlap.4 absorbable tacks were found fixed on the mesh and placed at: 0,4 cm (1), 1 cm (2) and 1,8 cm.The tacks were attached in the collagen direction towards the non-collagenous part.The pictures provided from the second surgical procedure showed that the mesh seems to be well fixed to the abdominal wall by the dermalon thread (pre-placed sutures that are not absorbable).A lack of fixation of the mesh is highly suspected and may explain the reported condition (the mesh has not fused with peritoneum).Moreover the fixation were placed within 1 cm, as recommended by the ifu.User error the visual examination of the provided sample / pictures was performed in collaboration with the textile principal engineer.The pictures provided from the second surgical procedure showed that the mesh seems to be well fixed to the abdominal wall by the dermalon thread (pre-placed sutures that are not absorbable).No information regarding the mesh appearance prior use, the mesh manipulation (hydration and placement) and the fixation (number of tacks applied) were provided.It should be noted that the description states that ¿a part of tacking came off and was found hanging in the abdominal cavity¿ and that ¿the thread for the plicated hernia orifice was also in the condition that had come off¿.The product ifu which accompanies each device states in chapter ¿description¿ that ¿ the collagen film is essentially degraded in less than 1 month¿ and in chapter ¿operating steps ¿ positioning¿ that ¿ 2.When putting it in place, it is essential to perfectly differentiate the film side from the porous textile side in order to situate the device correctly: the porous textile side is placed against the wall for tissue integration while the film side is facing the structures on which the tissular attachment is to be limited.3.The green marking is then pl aced against the abdominal wall¿.The mesh, confirmed by the visual examination of the returned sample, was well placed into the abdominal wall.The product ifu states in chapter ¿ operating steps ¿ positioning¿ that ¿ 6.(¿) the technique used to anchor the mesh (suture or staples) is left up to the practitioner.It is suggested to fixate the mesh at a distance of approximately 1cm from the edge of the mesh.¿ the analysis of the returned sample showed that some tacks were placed less than 1 cm from the edge of the mesh.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.A lack of fixation of the mesh is highly suspected and may explain the reported condition (the mesh has not fused with peritoneum).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.
Additional Manufacturer Narrative
Evaluation summary: a review of the device history has been performed and no failure that may relate to the reported conditions have been noted.Especially, the records related to the mechanical testing of the textile, the collagen film casting and drying were found within quality assurance (qa) specifications.The visual examination of the 3 provided pictures shows that during a surgery the mesh was visible, not attached to the abdominal wall on about half of the mesh.Two (2) resorbable staples were fixed on the mesh.The textile knitting pattern corresponded to a mesh (3ds).However the textile mrk was not visible on the pictures.An opaque layer was visible on the mesh textile covering the pores.The quality of the pictures did not allow us to confirm the reorder code and the collagen film.Conclusion of the visual examination: the reported condition was 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.No information regarding the mesh appearance prior use and the mesh manipulation (hydration and placement) were provided.The product instructions for use (ifu) which accompanies each device states in chapter ¿description¿ that ¿ the collagen film is essentially degraded in less than 1 month¿.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.No immediate action required.Without the sample a detailed investigation could not be perform and the root cause could not be determined.If additional information is obtained, or the sample is returned, we will re-open this investigation.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: 9708292
• Report Number: 9615742-2020-00375
• Device Sequence Number: 3392722
• Product Code: FTL
• UDI-Device Identifier: 10884521190405
• UDI-Public: 10884521190405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2020

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: 03/31/2024
• Device Model Number: SYM15F
• Device Catalogue Number: SYM15F
• Device Lot Number: PTC2739X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 05/12/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/10/2020; 05/28/2020
• 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 Weight: 74