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

Model Number PCO3020

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Anemia (1706); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Renal Failure (2041); Staphylococcus Aureus (2058); Sepsis (2067); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); Ascites (2596); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.The product was used for therapeutic treatment of a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrent ventral hernia, adhesions, mesh contained incarcerated bowel, perforated small bowel, inflammatory adhesions, infected mesh and small bowel fistula.The device had been used with alloderm regenerative tissue matrix.Post-operative patient treatment included revision surgery.Concomitant device: alloderm tissue matrix (102320, lot# b21413-071).

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrent ventral hernia, previous mesh disconnected around perimeter, abscess, adhesions, bacterial infection, open wound, mesh contained incarcerated bowel, perforated small bowel, small serosal tear, perforated viscus, ascites, inflammatory adhesions, infected mesh, brown fluid, fever, purulent fluid, intestine leakage, and small bowel fistula.The device had been used with alloderm regnerative tissue matrix and seprafilm.Post-operative patient treatment included revision surgery, removal of mesh, drainage of ascites, closure of perforation, repair of hernia with mesh, postoperative fluid collection, placement of drainage catheter, incision and drainage of abscess, lysis of adhesions, hospitalization, and bowel resection.

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 therapeutic treatment of a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrent ventral hernia, adhesions, mesh contained incarcerated bowel, perforated small bowel, inflammatory adhesions, infected mesh, intestine leakage, and small bowel fistula.The device had been used with alloderm regnerative tissue matrix.Post-operative patient treatment included revision surgery, removal of mesh, repair of hernia with mesh, incision and drainage of abscess, and bowel resection.

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(intestine leakage).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.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 recurrent ventral hernia.It was reported that after implant, the patient experienced recurrent ventral hernia, previous mesh disconnected around perimeter, abscess, adhesions, bacterial infection, open wound, mesh contained incarcerated bowel, perforated small bowel, small serosal tear, perforated viscus, ascites, inflammatory adhesions, infected mesh, brown fluid, fever, purulent fluid, intestine leakage, small bowel obstruction, pain, mesh erosion, infected mesh positive for mrsa, chronically incarcerated transverse colon, and small bowel fistula.The device had been used with alloderm regnerative tissue matrix and seprafilm.Post-operative patient treatment included revision surgery, removal of mesh, drainage of ascites, closure of perforation, repair of hernia with mesh, postoperative fluid collection, placement of drainage catheter, incision and drainage of abscess, lysis of adhesions, hospitalization, and bowel resection.

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 recurrent ventral hernia.It was reported that after implant, the patient experienced discomfort, sepsis, respiratory failure, renal failure, anemia, incarceration of hernia, recurrent ventral hernia, previous mesh disconnected around perimeter, abscess, adhesions, bacterial infection, open wound, mesh contained incarcerated bowel, perforated small bowel, small serosal tear, perforated viscus, ascites, inflammatory adhesions, infected mesh, brown fluid, fever, purulent fluid, intestine leakage, small bowel obstruction, pain, mesh erosion, infected mesh positive for mrsa, chronically incarcerated transverse colon, and small bowel fistula.The device had been used with alloderm regenerative tissue matrix and seprafilm.Post-operative patient treatment included medication, hospitalization for 111 days, icu stay for 72 days, long term acute hospital stay for 22 days, mechanical ventilation required for 63 days, tracheostomy, 25 blood transfusions, physical therapy for 24 days, iv antibiotics for more than 30 days, tpn for 12 days, jejunostomy for 84 days, use of drain, omentum and skin resection, ct scan, revision surgery, removal of mesh, drainage of ascites, closure of perforation, repair of hernia with mesh, postoperative fluid collection, placement of drainage catheter, incision and drainage of abscess, lysis of adhesions, and bowel resection.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• 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: 8515519
• MDR Text Key: 141972890
• Report Number: 9615742-2019-01298
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/29/2022

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: 04/30/2011
• Device Model Number: PCO3020
• Device Catalogue Number: PCO3020
• Device Lot Number: PGD00459
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019; 05/15/2019; 11/17/2021; 12/28/2022
• Supplement Dates FDA Received: 08/21/2019; 09/18/2019; 10/21/2019; 12/02/2021; 12/29/2022
• 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
• Treatment: ALLODERM (LOT# UNKNOWN), SEMPRAFIRM (LOT# UNKNOWN); ALLODERM TISSUE MATRIX (102320, LOT# B21413-071); ALLODERM TISSUE MATRIX (102320, LOT# B21413-071)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 127 KG