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

Model Number SYM3020OS

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

Patient Problems Abscess (1690); Fistula (1862); Hematoma (1884); Tissue Damage (2104); No Code Available (3191)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-open hernia surgery, patient developed wall abscess and was re-hospitalized.The mesh with lower hematoma was opened and continuous suction system is placed due to the bad appearance of the wall.Fistula was noted on (b)(6) 2019 and patient underwent reoperation and vacuum-assisted closure was changed.The mesh was resected and resection of the fistula with primary closure of the mesh with 15 cm bowel resection was done on (b)(6) 2019.This caused tissue loss.

Manufacturer Narrative

H3 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.Especially the record related to the sterilization (ref.(b)(4) on (b)(6) 2018) was found within specifications.No product and no picture were provided for evaluation.Without the sample a detailed investigation could not be performed.Sample disposition: n/a.Additionally, a review of the routine product bioburden and endotoxin monitoring results from (b)(6) 2017 until (b)(6) 2018 has been performed.This review confirmed that the bioburden and endotoxin results were within specifications limits for the concerned period.It should be noted that the mesh was placed in an open approach.The mesh was implanted the (b)(6) 2019.On (b)(6) 2019, the mesh and 15 cm of the bowel were resected.On (b)(6) 2019, a fistula was found.In addition it was specified that ¿attached photo, as you see after closing the fascia was placed a braun mesh of prolene which is the one seen in the photo ».The reported infection, hematoma and fistula are known potential complications of this type of surgery; this is a procedural related complication that is not normally attributed to any product/process deficiencies.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 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.Although a specific root cause analysis could not be performed, the incident is maintained in our database for a broader trend analysis.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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9786102
• MDR Text Key: 181961858
• Report Number: 9615742-2020-00546
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190535
• UDI-Public: 10884521190535
• Combination Product (y/n): N
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: SYM3020OS
• Device Catalogue Number: SYM3020OS
• Device Lot Number: PRL1157X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 88