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

Model Number PCO1510X

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Dyspnea (1816); Edema (1820); Erythema (1840); Fever (1858); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Perforation (2001); Pleural Effusion (2010); Pulmonary Edema (2020); Renal Failure (2041); Scar Tissue (2060); Scarring (2061); Sepsis (2067); Seroma (2069); Swelling (2091); Chills (2191); Electrolyte Imbalance (2196); Discharge (2225); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Skin Tears (2516); Ascites (2596); Blood Loss (2597); Bowel Perforation (2668); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Cardiovascular Insufficiency (4445); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

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 ventral hernia.It was reported that after implant, the patient experienced abscess, adhesions, draining open wound, phlegmon, infection, mesh was loose and hanging freely, and small bowel / enterocutaneous fistula.Post-operative patient treatment included abscess/incision drainage, debridement of abscess, wound vac, excision of phlegmon, mesh removal, lysis of adhesions, repair of small bowel enterotomies, small bowel resection, primary anastomosis, replacement of gastrostomy feeding tube, hernia repair with new mesh, jejunostomy tube placement, wound closure with demaclose device, irrigation, and debridement of abdominal wall.

Manufacturer Narrative

Patient codes-c64343 (free air, mass, exudate with lymphocytes and histiocytes, sinus tract, hypoechoic areas, gas) 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 ventral hernia.It was reported that after implant, the patient experienced abscess, adhesions, draining open wound, phlegmon, infection, mesh was loose and hanging freely, fluid collection, free air, edamatous changes, seroma, hematoma, small mass, inflammation, exudate with lymphocytes and histiocytes, fibrosis, sinus tract, small complex hypoechoic areas, left lung atelectasis, scarring, pulmonary interstitial edema, small bowel gas, obstrcution, ileus, pneumonitis, pleural effusion, pulmonary vascular congestion, redness, swelling, fever, chills, pressure sensation, purulent material, abdominal pain, shortness of breathe, indurated tissue, scar tissue, small bowel poking through abdominal wall, discharge, electrolyte normalities, renal failure, little to no abdominal wall left, suture line dehiscence, necrosis, nonfunctioning central line, succus and blood in pelvis, non-healing wound, sepsis, death, and small bowel / enterocutaneous fistula.Post-operative patient treatment included revision surgery, abscess/incision drainage, debridement of abscess, wound vac, excision of phlegmon, mesh removal/sutures, lysis of adhesions, repair of small bowel enterotomies, small bowel resection, primary anastomosis, replacement of gastrostomy feeding tube, hernia repair with new mesh, jejunostomy tube placement, wound closure with demaclose device, irrigation, closure of abdomen with sutures, admission to hospital, drain placement/removal, antibiotics, fold in the bowel oversewn, transferred to icu, washout, on tpn, placement of xenograft, removal of subclavian port, powerport placement to right chest, resuscitated, necrotic fat debrided, and debridement of abdominal wall.Information received indicates the patient is now deceased due to sepsis, with secondary diagnoses of complex abdominal wound, recurrent ventral hernia, and crohn¿s disease.

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.

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 abscess, adhesions, draining open wound, phlegmon, infection, mesh was loose and hanging freely, and small bowel / enterocutaneous fistula.Post-operative patient treatment included abscess / incision drainage, debridement of abscess, wound vac, excision of phlegmon, mesh removal, lysis of adhesions, repair of small bowel enterotomies, small bowel resection, primary anastomosis, replacement of gastrostomy feeding tube, hernia repair with new mesh, jejunostomy tube placement, wound closure with demaclose device, irrigation, closure of abdomen, and debridement of abdominal wall.

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 ventral hernia.It was reported that after implant, the patient experienced pain, perforation, mesh failure, abscess, adhesions, draining open wound, phlegmon, infection, mesh was loose and hanging freely, fluid collection, free air, edamatous changes, seroma, hematoma, small mass, inflammation, exudate with lymphocytes and histiocytes, fibrosis, sinus tract, small complex hypoechoic areas, left lung atelectasis, scarring, pulmonary interstitial edema, small bowel gas, obstrcution, ileus, pneumonitis, pleural effusion, pulmonary vascular congestion, redness, swelling, fever, chills, pressure sensation, purulent material, abdominal pain, shortness of breathe, indurated tissue, scar tissue, small bowel poking through abdominal wall, discharge, electrolyte normalities, renal failure, little to no abdominal wall left, suture line dehiscence, necrosis, nonfunctioning central line, succus and blood in pelvis, non-healing wound, sepsis, death, and small bowel / enterocutaneous fistula.Post-operative patient treatment included revision surgery, abscess/incision drainage, debridement of abscess, wound vac, excision of phlegmon, mesh removal/sutures, lysis of adhesions, repair of small bowel enterotomies, small bowel resection, primary anastomosis, replacement of gastrostomy feeding tube, hernia repair with new mesh, jejunostomy tube placement, wound closure with demaclose device, irrigation, closure of abdomen with sutures, admission to hospital, dr ain placement/removal, antibiotics, fold in the bowel oversewn, transferred to icu, washout, on tpn, placement of xenograft, removal of subclavian port, powerport placement to right chest, resuscitated, necrotic fat debrided, ct-scan, and debridement of abdominal wall.Information received indicates the patient is now deceased, due to sepsis listed as immediate cause of death, with secondary diagnoses of complex abdominal wound, recurrent ventral hernia, and crohn¿s disease.

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 pain, perforation, mesh failure, abscess, adhesions, draining open wound, phlegmon, infection, mesh was loose and hanging freely, fluid collection, free air, edamatous changes, seroma, hematoma, small mass, inflammation, exudate with lymphocytes and histiocytes, fibrosis, sinus tract, small complex hypoechoic areas, left lung atelectasis, scarring, pulmonary interstitial edema, small bowel gas, obstruction, ileus, pneumonitis, pleural effusion, pulmonary vascular congestion, redness, swelling, fever, chills, pressure sensation, purulent material, abdominal pain, shortness of breathe, indurated tissue, scar tissue, small bowel poking through abdominal wall, discharge, electrolyte abnormalities, renal failure, little to no abdominal wall left, suture line dehiscence, necrosis, nonfunctioning central line, succus and blood in pelvis, non-healing wound, sepsis, small bowel / enterocutaneous fistula, weakness, dyspnea, malnutrition, hypokalemia, skin breakdown, dehiscence, death.Post-operative patient treatment included revision surgery, abscess/incision drainage, debridement of abscess, wound vac, excision of phlegmon, mesh removal/sutures, lysis of adhesions, repair of small bowel enterotomies, small bowel resection, primary anastomosis, replacement of gastrostomy feeding tube, hernia repair with new mesh, jejunostomy tube placement, wound closure with demaclose device, irrigation, closure of abdomen with sutures, admission to hospital, drain placement/removal, antibiotics, fold in the bowel over sewn, transferred to icu, washout, on tpn, placement of xenograft, removal of subclavian port, powerport placement to right chest, resuscitated, necrotic fat debrided, ct-scan, and debridement of abdominal wall.Information received indicates the patient is now deceased, due to sepsis listed as immediate cause of death, with secondary diagnoses of complex abdominal wound, recurrent ventral hernia, and crohn¿s disease.

Manufacturer Narrative

Additional info: b5, b7, h6 (patient codes, ime e2402: malnutrition).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PARIETEX
• 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: 10379896
• MDR Text Key: 202054174
• Report Number: 9615742-2020-01754
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179707
• UDI-Public: 10884521179707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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: 04/25/2024

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: 09/30/2018
• Device Model Number: PCO1510X
• Device Catalogue Number: PCO1510X
• Device Lot Number: PNJ0054X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 07/22/2020; 11/23/2022; 04/17/2024
• Supplement Dates FDA Received: 08/11/2020; 08/17/2020; 12/01/2022; 04/25/2024
• Date Device Manufactured: 10/16/2013
• 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): Hospitalization; Required Intervention; Death
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White