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

Model Number SYM1510

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Edema (1820); Inflammation (1932); Nausea (1970); Sepsis (2067); Vomiting (2144); Hernia (2240); Peritonitis (2252); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a laparoscopic parastomal hernia repair using composite mesh with enterolysis and mobilization of small bowel.She had revision surgery 1 years and 8 months post-surgery.The patient experienced multiple surgical revisions, recurrent hernia, incarcerated small bowel inside of a large parastomal hernia, adhesions, bowel stuck to hernia sac, relocation of stoma.Please also reference pe# (b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a laparoscopic parastomal hernia repair using composite mesh with enterolysis and mobilization of small bowel.She had revision surgery 1 years and 8 months post-surgery.The patient experienced multiple surgical revisions, recurrent hernia, incarcerated small bowel inside of a large parastomal hernia, adhesions, bowel stuck to hernia sac, relocation of stoma.

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.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a parastomal hernia.It was reported that after implant, the patient experienced recurrence, adhesions, bowel stuck to hernia sac, excessive bleeding, small bowel obstruction, edema of the mesentery, abscess, purulence around mesh, open abdomen, and abdominal sepsis.Post-operative patient treatment included revision surgery, relocation of stoma, exploratory laparotomy with small bowel resection, parastomal hernia repair with mesh, hernia repair with sutures, lysis of adhesions, mesh removal, hernia sac partially excised, functional ileostomy obstruction, revision of ileostomy, excision of mesh, abdominal washout and exploration, egd, wound vac, bowel was dilated and contents were milked back toward the stomach and through ng tube, and abdomen was thoroughly irrigated.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.H6: patient code: c64343 (leukocytosis, small amounts of free air).D11: concomitant device: gore f52030 bio-a mesh, lot 11680044, unknown parietex product (unknown lot #).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.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a parastomal hernia.It was reported that after implant, the patient experienced recurrence, adhesions, bowel stuck to hernia sac, excessive bleeding, small bowel obstruction, edema of the mesentery, abscess, purulence around mesh, open abdomen, abdominal sepsis, leukocytosis, small amounts of free air, abdominal pain, nausea, vomiting, edema of mesentery, peritonitis, inflamed intestine walling.Post-operative patient treatment included revision surgery, relocation of stoma, exploratory laparotomy with small bowel resection, parastomal hernia repair with mesh, hernia repair with sutures, lysis of adhesions, mesh removal, hernia sac partially excised, functional ileostomy obstruction, revision of ileostomy, excision of mesh, abdominal washout and exploration, egd, wound vac, bowel was dila ted and contents were milked back toward the stomach and through ng tube, and abdomen was thoroughly irrigated.

• 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: 8682468
• MDR Text Key: 147448534
• Report Number: 9615742-2019-01884
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190375
• UDI-Public: 10884521190375
• Combination Product (y/n): N
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: SYM1510
• Device Catalogue Number: SYM1510
• Device Lot Number: PNJ0237X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PARIETEX.; UNKNOWN ABSORBATACK (LOT# UNKNOWN).; PARIETEX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 73