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

Model Number PCO12X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Internal Organ Perforation (1987); Perforation (2001); Pleural Effusion (2010); Sepsis (2067); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: pco20, lot number: plb00291; pco12x , lot number: plh00283.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 incarcerated incisional hernias.It was reported that after a procedure where this device was implanted, the patient experienced multiple surgical revisions, recurrent incarcerated incisional hernias requiring placement of new mesh for repair, dense adhesions (lysed over 2.5 hours), enterotomy repair, effaced bowel, excision, infection, abdominal abscess, small bowel perforation, foul-smelling puss from abdominal wound, placement of wound vac because they were unable to close the abdominal wall d/t bowel perforation and open wound, primary repair of small bowel perforation and exchange of wound vac, abdominal wound sepsis, wound exploration, removal of wound vac, incision and drainage of right lateral abdominal wall, placement of new mesh to repair defect, small bowel obstruction.After treatment, the patient experienced revision surgery.

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 incarcerated incisional hernias in a laparoscopic repair.It was reported that after implant, the patient experienced recurrence, wound infections, abscess, small bowel perforation, abdominal wound sepsis, extensive inflammation, underlying developing necrotizing fasciitis cannot be excluded, fistula, purulent material, non-healing wound, effaced bowel, foul-smelling pus from abdominal wound, adhesions, fevers, erythema, and small bowel obstruction.Post-operative patient treatment included multiple surgical revisions, wound exploration with primary repair of small bowel perforation, drainage of abdominal abscess, wound vac placement, picc line placement, ct guided fluid collection, abdominal wound closure with cook biologic mesh, incision and drainage of right lateral abdominal wall, antibiotics, wound irrigation, resection of small bowel with primary anastomosis, repair of enterotomy, extensive lysis of adhesions, removal of mesh, prolene sutures removed, repair of hernia with mesh, debridement and undermining of skin flaps.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of incarcerated incisional hernias.It was reported that after implant, the patient experienced recurrence, wound infections, abscess, small bowel perforation, abdominal wound sepsis, extensive inflammation, underlying developing necrotizing fasciitis cannot be excluded, fistula, purulent material, non-healing wound, effaced bowel, foul-smelling pus from abdominal wound, adhesions, and small bowel obstruction.Post-operative patient treatment included multiple surgical revisions, wound exploration with primary repair of small bowel perforation, drainage of abdominal abscess, wound vac placement, picc line placement, ct guided fluid collection, abdominal wound closure with cook biologic mesh, incision and drainage of right lateral abdominal wall, antibiotics, wound irrigation, resection of small bowel with primary anastomosis, repair of enterotomy, extensive lysis of adhesions, removal of mesh, prolene sutures removed, repair of hernia with mesh, debridement and undermining of skin flaps.

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 incarcerated incisional hernias.It was reported that after a procedure where this device was implanted, the patient experienced multiple surgical revisions, recurrent incarcerated incisional hernias requiring placement of new mesh for repair, dense adhesions (lysed over 2.5 hours), enterotomy repair, effaced bowel, excision, infection, abdominal abscess, small bowel perforation, foul-smelling pus from abdominal wound, placement of wound vac because they were unable to close the abdominal wall due to bowel perforation and open wound, primary repair of small bowel perforation and exchange of wound vac, abdominal wound sepsis, wound exploration, removal of wound vac, incision and drainage of right lateral abdominal wall, placement of new mesh to repair defect, small bowel obstruction.After treatment, the patient experienced revision surgery.

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

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 incarcerated incisional hernias in a laparoscopic repair.It was reported that after implant, the patient experienced recurrence, wound infections, wound dehiscence, abscess, small bowel perforation, abdominal wound sepsis, extensive inflammation, underlying developing necrotizing fasciitis cannot be excluded, fistula, purulent material, non-healing wound, effaced bowel, foul-smelling pus from abdominal wound, adhesions, fevers, erythema, and small bowel obstruction.Post-operative patient treatment included multiple surgical revisions, wound exploration with primary repair of small bowel perforation, drainage of abdominal abscess, wound vac placement, picc line placement, ct guided fluid collection, abdominal wound closure with cook biologic mesh, incision and drainage of right lateral abdominal wall, antibiotics, wound irrigation, resection of small bowel with primary anastomosis, repair of enterotomy, extensive lysis of adhesions, removal of mesh, prolene sutures removed, repair of hernia with mesh, debridement and undermining of skin flaps.

• 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: 8600610
• MDR Text Key: 144728427
• Report Number: 9615742-2019-01674
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179745
• UDI-Public: 10884521179745
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: PCO12X
• Device Catalogue Number: PCO12X
• Device Lot Number: PLI00523
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 98