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

Model Number PCO2520

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Abdominal Distention (2601); No Code Available (3191); Unspecified Tissue Injury (4559)

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 large complex recurrent incarcerated incisional ventral hernia with diastasis.The procedure involved primary fascial repair, underlay of the mesh, laparoscopic diastasis recti repair, and placement of an external pain pump.During the procedure, omental adhesions to the fascial defects were found.It was reported that after a procedure where this device was implanted, the patient experienced mesh failure; recurrence, bile reflux esophagitis, nonalcoholic steatohepatitis, meckel's diverticulum, and adhesion removal.Treatment included an enterectomy with enteroenterostomy, resection of meckel's diverticulum, recurrent incarcerated incisional ventral hernia repair with primary closure of fascial defect, open wedge biopsy of the liver, autologous platelet grafting, placement of external pain pump and transversus abdominis plane, and regional anesthesia block.During the treatment a split in the hernia mesh of 4cm was noted that may have been purposefully split to gain access to the abdominal cavity.Multiple adhesions were also noted on the undersurface of the mesh, which was securely incorporated into the anterior abdominal wall.

Manufacturer Narrative

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.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 large complex recurrent incarcerated incisional ventral hernia with diastasis.It was reported that after implant, the patient experienced mesh failure, recurrence, bile reflux esophagitis, nonalcoholic steatohepatitis, meckel's diverticulum, and adhesions.Post-operative patient treatment included an enterectomy with enteroenterostomy, resection of meckel's diverticulum, recurrent incarcerated incisional ventral hernia repair with primary closure of fascial defect, open wedge biopsy of the liver, autologous platelet grafting, placement of external pain pump and transversus abdominis plane, and regional anesthesia block.During the treatment a split in the hernia mesh of 4c m was noted that may have been purposefully split to gain access to the abdominal cavity.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional ventral hernia.It was reported that after the underlay implant, the patient experienced mesh split, mesh failure, recurrence, bile reflux esophagitis, nonalcoholic steatohepatitis, meckel's diverticulum, infection, pain, adhesions, bulge, inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, and mesh migration.Post-operative patient treatment included an enterectomy with enteroenterostomy, resection of meckel's diverticulum, recurrent incarcerated incisional ventral hernia repair with primary closure of fascial defect, open wedge biopsy of the liver, autologous platelet grafting, placement of external pain pump and transversus abdominis plane, regional anesthesia block, revision surgery, mesh revision surgery, medication, and mesh removal.

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

Additional information: b5, d11, g4, d11-concomitant product: 174006 protack 5mm disp in)product id: 174006, lot#: pqb0250; psl0832).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 an incisional ventral hernia.It was reported that after implant, the patient experienced mesh failure, recurrence, bile reflux esophagitis, nonalcoholic steatohepatitis, meckel's diverticulum, and adhesions.Post-operative patient treatment included an enterectomy with enteroenterostomy, resection of meckel's diverticulum, recurrent incarcerated incisional ventral hernia repair with primary closure of fascial defect, open wedge biopsy of the liver, autologous platelet grafting, placement of external pain pump and transversus abdominis plane, regional anesthesia block, revision surgery, and mesh removal.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional ventral hernia.It was reported that after the underlay implant, the patient experienced mesh failure, recurrence, bile reflux esophagitis, nonalcoholic steatohepatitis, meckel's diverticulum, adhesions, bulge, and mesh migration.Post-operative patient treatment included an enterectomy with enteroenterostomy, resection of meckel's diverticulum, recurrent incarcerated incisional ventral hernia repair with primary closure of fascial defect, open wedge biopsy of the liver, autologous platelet grafting, placement of external pain pump and transversus abdominis plane, regional anesthesia block, revision surgery, mesh revision surgery, and mesh removal.

Manufacturer Narrative

D11 concomitant product: 174006 protack 5mm disp in (lot# p0b0250); 174006 protack 5mm disp in (lot# p9l0832).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.

Manufacturer Narrative

Additional information: b5, d8, g3, h6 correction: e1(facility name, street 1, city, region, and postal code), g1(mfr contact first name, last name, street 1, mfr city, region, postal code, email and phone number).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 an incisional ventral hernia.It was reported that after the underlay implant, the patient experienced mesh failure, recurrence, bile reflux esophagitis, nonalcoholic steatohepatitis, meckel's diverticulum, infection, pain, adhesions, bulge, and mesh migration.Post-operative patient treatment included an enterectomy with enteroenterostomy, resection of meckel's diverticulum, recurrent incarcerated incisional ventral hernia repair with primary closure of fascial defect, open wedge biopsy of the liver, autologous platelet grafting, placement of external pain pump and transversus abdominis plane, regional anesthesia block, revision surgery, mesh revision surgery, and mesh removal.

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 laparoscopic therapeutic treatment of an incisional ventral hernia.It was reported that after the underlay implant, the patient experienced mesh failure, recurrence, bile reflux esophagitis, nonalcoholic steatohepatitis, meckel's diverticulum, infection, pain, adhesions, bulge, inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, and mesh migration.Post-operative patient treatment included an enterectomy with enteroenterostomy, resection of meckel's diverticulum, recurrent incarcerated incisional ventral hernia repair with primary closure of fascial defect, open wedge biopsy of the liver, autologous platelet grafting, placement of external pain pump and transversus abdominis plane, regional anesthesia block, revision surgery, mesh revision surgery, and mesh removal.

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.

• 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: 7673794
• MDR Text Key: 113541995
• Report Number: 9615742-2018-01526
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2014
• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: PJF00016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• 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: SEE SECTION H10; SEE SECTION H10..
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 132 KG