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

Model Number PCO1510

Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Corneal Pannus (1447); Adhesion(s) (1695); Atrial Fibrillation (1729); Autoimmune Disorder (1732); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Lupus (1956); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Renal Failure (2041); Sepsis (2067); Septic Shock (2068); Thrombosis (2100); Urinary Tract Infection (2120); Hernia (2240); Ulcer (2274); Anxiety (2328); Injury (2348); Fungal Infection (2419); Blood Loss (2597); No Code Available (3191); Constipation (3274); Thrombosis/Thrombus (4440); 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 midline incisional hernia.It was reported that after implant, the patient experienced severe pain, adhesions, fistula, mesh erosion into colon, colon perforation from mesh and skin necrosis overlying mesh, enterocolic fistula from mesh eroding into colon, end stage renal failure, candida fungemia, (b)(6), multiple skin bullae.Treatment provided for these conditions include extensive lysis of adhesions and mesh removal.

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.Concomitant medical products: pco2520 comp 3dpy 25x20 cm no thr (lot# pgi00772), pco2520 comp 3dpy 25x20 cm no thr (lot# pgj00417).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 midline incisional hernia.It was reported that after implant, the patient experienced severe pain, adhesions, fistula, mesh erosion into colon, colon perforation from mesh and skin necrosis overlying mesh, enterocolic fistula from mesh eroding into colon, clotting, end stage renal failure, candida fungemia, epstein-barr viremia, infection, multiple skin bullae.Post-operative patient treatment included revision surgery, mesh removal, lysis of adhesions, take down of fistula, reopening of recent incision, evacuation of clot, wound vac, and hernia could not be repaired because doctor was worried the body was too unstable.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a midline incisional hernia.It was reported that after implant, the patient experienced severe pain, adhesions, mesh erosion into colon, colon perforation, enterocolic fistula from mesh eroding into colon, clotting, end stage renal failure, candida fungemia, epstein-barr viremia, infection, thrombocytopenia, intrabdominal free air, sepsis, uti, livedo reticularis, atrial fibrillation, perforated viscus, pannus, ischemic and non-viable tissue, necrosis, systemic lupus erythematosus, hemodynamic instability, brisk bleeding, inflammatory ulcers, septic shock, clot, lesions, invasive fungal wound, and multiple skin bullae.Post-operative patient treatment included revision surgery, 90% mesh removal, lysis of adhesions, take down of fistula, wound debridement, colectomy, evacuation of clot, wound vac, antibiotics, tracheostomy, icu, evacuation of clot, colo-colo anastomosis, punch biopsies of the abdominal wall skin lesions, debridement of necrotizing soft tissue infection abdomen to fascial level, decannulation, and side to side anastomosis of the transverse colon with freeing of the hepatic flexure and splenic flexure.

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 laparoscopic therapeutic treatment of a midline incisional hernia.It was reported that after implant, the patient experienced severe pain, adhesions, mesh erosion into colon, colon perforation, enterocolic fistula from mesh eroding into colon, clotting, end stage renal failure, candida fungemia, epstein-barr viremia, infection, thrombocytopenia, intrabdominal free air, sepsis, uti, livedo reticularis, atrial fibrillation, perforated viscus, pannus, ischemic and non-viable tissue, necrosis, systemic lupus erythematosus, hemodynamic instability, brisk bleeding, inflammatory ulcers, septic shock, clot, lesions, invasive fungal wound, recurrence, digestive issues, constipation, anxiety, loss of enjoyment of life, and multiple skin bullae.Post-operative patient treatment included revision surgery, 90% mesh removal, lysis of adhesions, take down of fistula, wound debridement, colectomy, evacuation of clot, wound vac, antibiotics, tracheostomy, icu, 3 month hospitalization, abdominal wall reconstruction, evacuation of clot, colo-colo anastomosis, punch biopsies of the abdominal wall skin lesions, debridement of necrotizing soft tissue infection abdomen to fascial level, hernia repair with new mesh, chest films, decannulation, and side to side anastomosis of the transverse colon with freeing of the hepatic flexure and splenic flexure.Relevant tests/laboratory data: (b)(6) 2017 abdominal and chest films showed intraabdominal free air.(b)(6) 2017: op note stated development of thrombocytopenia.

Manufacturer Narrative

Additional information: b5, b7, e1 (facility name, street 1, city, region, postal code), g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h4, h6 (patient codes), additional code 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 ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8140339
• MDR Text Key: 129567433
• Report Number: 9615742-2018-02689
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050187
• 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
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: PCO1510
• Device Catalogue Number: PCO1510
• Device Lot Number: PGG00219
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2023
• Date Device Manufactured: 07/11/2006
• 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 H10 NOTES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 63 KG