MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO15X

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

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Death (1802); Purulent Discharge (1812); Edema (1820); Fistula (1862); Ischemia (1942); Pain (1994); Injury (2348)

Event Type  Death  

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.The product was used for therapeutic treatment of a ventral hernia.The patient underwent a laparoscopic ventral hernia repair as well as lysis.It was reported that after implant, the patient experienced pain, adhesions, fistula, and bacterial infection (mrsa).The device had been used with a covidien tacking device (lot# n5l0761wmx).Post-operative patient treatment included take down of enterocolonic fistula, small bowel resection and abdominal wound vacuum-assisted closure placement ((b)(6) 2016, (b)(6) 2016, (b)(6) 2016).Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.

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.Removed (added patient code: (b)(6) and removed (b)(6) 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.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced pain, adhesions, fistula, small bowel ischemia, and bacterial infection (mrsa).Post-operative patient treatment included take down of entercolonic fistula, small bowel resection, lysis of adhesions, exploratory laparotomy, hand sewn small bowel anastomosis, ileostomy creation, liver biopsy, abdominal wound washout, state 1 grecian procedure, and abdominal wound vacuum-assisted closure placement.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.

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.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.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced pain, adhesions, fistula, small bowel ischemia, small bowel evisceration, edema, brown murky fluid, and bacterial infection (mrsa).Post-operative patient treatment included take down of enterocolonic fistula, small bowel resection, several enterotomies present, lysis of adhesions, exploratory laparotomy, hand sewn small bowel anastomosis, ileostomy creation, liver biopsy, abdominal wound washout, state 1 grecian procedure, and abdominal wound vacuum-assisted closure placement.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8345361
• MDR Text Key: 136336132
• Report Number: 9615742-2019-00305
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179790
• UDI-Public: 10884521179790
• Combination Product (y/n): N
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: PCO15X
• Device Catalogue Number: PCO15X
• Device Lot Number: POF0747X
• 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: ABSTACK30(LOT#: N5L0761WMX)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 55 YR