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

Model Number PCO20

Device Problems Material Perforation (2205); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); No Code Available (3191); Nodule (4551); 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 an incisional hernia.It was reported that after implant, the patient experienced recurrence, multiple fascial defect consistent with small swiss cheese like deformities through her midline fascia, seroma, small defect in omentum, extremely large pelvic mass, cystic degeneration of multiple uterine myomas, large piece of mesh in the upper abdomen that had portions of omentum adherent to it, dehiscence evidence of an incisional hernia repair, large subcutaneous abscess, bowel perforation, large loop of small bowel herniated fascia and had become obstructed, extensive adhesions, loss of domain with massive abdominal wall defect, left abdominal wall fascia retracted back significantly nearly to flank, non-healing wound, and necrosis.Post-operative patient treatment included repair of recurrent incarcerated incisional hernia with new mesh, seroma cavity was drained, removal of covidien mesh, dissection of omentum of mesh and resection of abdominal wall mesh, removal of the majority of the infracolic omentum, total abdominal hysterectomy, bilateral salpingo-oophorectomy, partial omentectomy, resection of approximately 40 cm of mid jejunum, wound vac closure of abdomen and abdominal washout, removal of old mesh, large recurrent incisional hernia repair with new strattice mesh, enterotomy in distal ileum, resection of necrosis of skin edges, and skin was brought together in the midline with sutures followed by surgical clips on the skin.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, multiple fascial defect consistent with small swiss cheese like deformities through her midline fascia, seroma, small defect in omentum, extremely large pelvic mass, cystic degeneration of multiple uterine myomas, large piece of mesh in the upper abdomen that had portions of omentum adherent to it, dehiscence evidence of an incisional hernia repair, large subcutaneous abscess, bowel perforation, large loop of small bowel herniated fascia and had become obstructed, extensive adhesions, loss of domain with massive abdominal wall defect, left abdominal wall fascia retracted back significantly nearly to flank, non-healing wound, and necrosis.Post-operative patient treatment included repair of recurrent incarcerated incisional hernia with new mesh, seroma cavity was drained, removal of covidien mesh, dissection of omentum of mesh and resection of abdominal wall mesh, removal of the majority of the infracolic omentum, total abdominal hysterectomy, bilateral salpingo-oophorectomy, partial omentectomy, resection of approximately 40 cm of mid jejunum, wound vac closure of abdomen and abdominal washout, removal of old mesh, large recurrent incisional hernia repair with new strattice mesh, enteromy in distal ileum, resection of necrosis of skin edges, and skin was brought together in the midline with sutures followed by surgical clips on the skin.

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.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 incisional hernia.It was reported that after implant, the patient experienced recurrence, multiple fascial defect consistent with small swiss cheese like deformities through her midline fascia, seroma, small defect in omentum, extremely large pelvic mass, cystic degeneration of multiple uterine myomas, large piece of mesh in the upper abdomen that had portions of omentum adherent to it, dehiscence evidence of an incisional hernia repair, large subcutaneous abscess, bowel perforation, large loop of small bowel herniated fascia and had become obstructed, extensive adhesions, loss of domain with massive abdominal wall defect, left abdominal wall fascia retracted back significantly nearly to flank, non-healing wound, infection and necrosis.Post-operative patient treatment included repair of recurrent incarcerated incisional hernia with new mesh, seroma cavity was drained, removal of covidien mesh, dissection of omentum of mesh and resection of abdominal wall mesh, removal of the majority of the infracolic omentum, total abdominal hysterectomy, bilateral salpingo-oophorectomy, partial omentectomy, resection of approximately 40 cm of mid jejunum, wound vac closure of abdomen and abdominal washout, removal of old mesh, large recurrent incisional hernia repair with new strattice mesh, enteromy in distal ileum, resection of necrosis of skin edges, and skin was brought together in the midline with sutures followed by surgical clips on the skin.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced recurrence, multiple fascial defect consistent with small swiss cheese like deformities through her midline fascia, seroma, small defect in omentum, extremely large pelvic mass, cystic degeneration of multiple uterine myomas, large piece of mesh in the upper abdomen that had portions of omentum adherent to it, dehiscence evidence of an incisional hernia repair, large subcutaneous abscess, bowel perforation, large loop of small bowel herniated fascia and had become obstructed, extensive adhesions, loss of domain with massive abdominal wall defect, left abdominal wall fascia retracted back significantly nearly to flank, non-healing wound, infection and necrosis.Post-operative patient treatment included repair of recurrent incarcerated incisional hernia with new mesh, seroma cavity was drained, removal of covidien mesh, dissection of omentum of mesh and resection of abdominal wall mesh, removal of the majority of the infracolic omentum, total abdominal hysterectomy, bilateral salpingo-oophorectomy, partial omentectomy, resection of approximately 40 cm of mid jejunum, wound vac closure of abdomen and abdominal washout, removal of old mesh, large recurrent incisional hernia repair with new strattice mesh, enteromy in distal ileum, resection of necrosis of skin edges, and skin was brought together in the midline with sutures followed by surgical clips on the skin.

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.

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 a ventral incisional hernia.It was reported that after implant, the patient experienced abdominal pain, pain, inflammation, mesh failure, incarcerated omentum herniated up beyond edges of mesh, recurrence, multiple fascial defect consistent with small swiss cheese like deformities through her midline fascia, seroma, small defect in omentum, extremely large pelvic mass, cystic degeneration of multiple uterine myomas, large piece of mesh in the upper abdomen that had portions of omentum adherent to it, dehiscence evidence of an incisional hernia repair, large subcutaneous abscess, bowel perforation, large loop of small bowel herniated fascia and had become obstructed, extensive adhesions, loss of domain with massive abdominal wall defect, left abdominal wall fascia retracted back significantly nearly to flank, non-healing wound, infection and necrosis.Post-operative patient treatment included lysis of adhesions, omentectomy, use of jp drains, medication, repair of recurrent incarcerated incisional hernia with new mesh, seroma cavity was drained, removal of covidien mesh, dissection of omentum of mesh and resection of abdominal wall mesh, removal of the majority of the infracolic omentum, total abdominal hysterectomy, bilateral salpingo-oophorectomy, partial omentectomy, resection of approximately 40 cm of mid jejunum, wound vac closure of abdomen and abdominal washout, removal of old mesh, large recurrent incisional hernia repair with new strattice mesh, enteromy in distal ileum, resection of necrosis of skin edges, and skin was brought together in the midline with sutures followed by surgical clips on the skin.

Manufacturer Narrative

Additional info: a4, b5, b7, g1, g3, h6 (added patient codes and device codes, ime e2402: "small defect in omentum, extremely large pelvic mass, cystic degeneration of multiple uterine myomas" and "loss of domain with abdominal wall defect, left abdominal wall fascia retracted back to flank").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.

• 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: 8491521
• MDR Text Key: 141196924
• Report Number: 9615742-2019-01083
• 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: 11/30/2022

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: 04/30/2012
• Device Model Number: PCO20
• Device Catalogue Number: PCO20
• Device Lot Number: PHE00147
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 05/15/2019; 05/15/2019; 01/12/2022; 11/16/2022; 11/30/2022
• Supplement Dates FDA Received: 05/13/2019; 08/29/2019; 10/31/2019; 01/31/2022; 11/21/2022; 11/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 95 KG