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

Model Number PCO6VP

Device Problems Loss of or Failure to Bond (1068); Material Erosion (1214); Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Death (1802); Emotional Changes (1831); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Nausea (1970); Pain (1994); Perforation (2001); Scar Tissue (2060); Septic Shock (2068); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 midabdominal ventral hernia.It was reported that after implant, the patient experienced severe abdominal pain, nausea, vomiting, recurrence, and loose mesh from its lateral attachments and folded on itself, so that the rough side was toward the bowel.Multiple loops of bowel adhered to the mesh and the mesh eroded into the bowel.Post-operative patient treatment included removal surgery.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.

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 midabdominal ventral hernia.It was reported that after implant, the patient experienced severe abdominal pain, nausea, vomiting, recurrence, and loose mesh from its lateral attachments and folded on itself so that the rough side was toward the bowel.Multiple loops of bowel adhered to the mesh and the mesh eroded into the bowel.Post-operative patient treatment included removal surgery.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a midabdominal ventral hernia.It was reported that after implant, the patient experienced perforated bowel, infection, severe abdominal pain, nausea, vomiting, recurrence, and loose mesh from its lateral attachments and folded on itself so that the rough side was toward the bowel.Multiple loops of bowel adhered to the mesh and the mesh eroded into the bowel.Post-operative patient treatment included small bowel resection and removal surgery.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.Additional information: b5, g4, h6 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

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 therapeutic treatment of a midabdominal ventral hernia.It was reported that after implant, the patient experienced perforated bowel, infection, severe abdominal pain, nausea, vomiting, recurrence, ischemic changes in the bowel, free air in the abdomen, septic shock, death, small bowel obstruction, failure of mesh, defective mesh, scarring, mental pain, pain, permanent impairment, loss of enjoyment of life, mesh came loose from its lateral attachments and folded on itself so that the rough side was toward the bowel, multiple loops of bowel adhered to the mesh, and the mesh eroded into the bowel.Post-operative patient treatment included small bowel resection, and removal surgery.Information received indicates the patient is now deceased, due to septic shock and small bowel obstruction.

Manufacturer Narrative

Additional information: h6 (patient codes), additional codes.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 therapeutic treatment of a midabdominal ventral hernia.It was reported that after implant, the patient experienced perforated bowel, infection, severe abdominal pain, nausea, vomiting, recurrence, ischemic changes in the bowel, free air in the abdomen, septic shock, death, small bowel obstruction, failure of mesh, defective mesh, scarring, mental pain, pain, permanent impairment, loss of enjoyment of life, mesh came loose from its lateral attachments and folded on itself so that the rough side was toward the bowel, multiple loops of bowel adhered to the mesh, and the mesh eroded into the bowel.Post-operative patient treatment included small bowel resection, mesh removal surgery, ct-scan, and medication.Information received indicates the patient is now deceased, due to septic shock and small bowel obstruction.Relevant tests/laboratory data: (b)(6) 2017 - pathology report from hernia sac specimen showed chronic reactive change.(b)(6) 2017 - ct of abdomen (per op note) showed proximal bowel dilation, recurrence of her ventral hernia with a piece of incarcerated and possible strangulated bowel, significant ischemic changes in the bowel, and free air in the abdomen.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8434874
• MDR Text Key: 139285048
• Report Number: 9615742-2019-00504
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514157
• UDI-Public: 10884521514157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/21/2024

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: 11/30/2021
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PQL0441X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 03/20/2019; 05/15/2019; 03/30/2022; 02/14/2024
• Supplement Dates FDA Received: 03/25/2019; 10/14/2019; 04/19/2022; 02/21/2024
• Date Device Manufactured: 12/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Death
• Patient Sex: Female
• Patient Weight: 57 KG