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

Model Number PCO2015X

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Purulent Discharge (1812); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Rash (2033); Seroma (2069); Vomiting (2144); Chills (2191); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); 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 a ventral hernia.It was reported that after implant, the patient experienced abdominal abscess with small-bowel fistula, infected mesh, defect in the anterior wall of the small bowel, and serosal defects.It is noted that two areas of dense matting were unable to be freed up due to previously placed ingrown mesh in the fistula.Post-operative treatment required included exploratory laparotomy, adhesiolysis, wound vac was placed into the subcutaneous tissue, tube jejunostomy, small bowel resection, defects closed with 3-0 vicryl, implantation of new mesh, and mesh removal.

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.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 hernia.It was reported that after implant, the patient experienced abdominal abscess with small-bowel fistula, infected mesh, defect in the anterior wall of the small bowel, adhesions, serosal defects, open wound, necrotic tissue, purulent material, and ischemic looking bowel.It is noted that two areas of dense matting were unable to be freed up due to previously placed ingrown mesh in the fistula.Post-operative treatment required included exploratory laparotomy, adhesiolysis, repair of small bowel, wound vac was placed into the subcutaneous tissue, tube jejunostomy, small bowel resection, defects closed with 3-0 vicryl, implantation of new life cell stratice mesh, and mesh removal.

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 abdominal abscess with small-bowel fistula, infected mesh, defect in the anterior wall of the small bowel, adhesions, open wound, and serosal defects.It is noted that two areas of dense matting were unable to be freed up due to previously placed ingrown mesh in the fistula.Post-operative treatment required included exploratory laparotomy, adhesiolysis, repair of small bowel, wound vac was placed into the subcutaneous tissue, tube jejunostomy, small bowel resection, defects closed with 3-0 vicryl, implantation of new life cell stratice mesh, 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.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.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 hernia.It was reported that after implant, the patient experienced abdominal abscess with small-bowel fistula, infected mesh, defect in the anterior wall of the small bowel, adhesions, serosal defects, open wound, necrotic tissue, purulent material, small bowel obstruction, chronic pain, mesh erosion, ingrown mesh to fistula and ischemic looking bowel.It is noted that two areas of dense matting were unable to be freed up due to previously placed ingrown mesh in the fistula.Post-operative treatment required included exploratory laparotomy, adhesiolysis, repair of small bowel, wound vac was placed into the subcutaneous tissue, tube jejunostomy, small bowel resection, defects closed with 3-0 vicryl, implantation of new life cell stratice mesh, 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 a ventral hernia.It was reported that after implant, the patient experienced adhesions, perforation, abdominal abscess with small-bowel fistula, infected mesh, defect in the anterior wall of the small bowel, adhesions, serosal defects, open wound, necrotic tissue, purulent material, small bowel obstruction, chronic pain, mesh erosion, ingrown mesh to fistula and ischemic looking bowel.It is noted that two areas of dense matting were unable to be freed up due to previously placed ingrown mesh in the fistula.Post-operative treatment required included medication, multiple french drains, repair of colotomy.Exploratory laparotomy, adhesiolysis, repair of small bowel, wound vac was placed into the subcutaneous tissue, tube jejunostomy, small bowel resection, defects closed with 3-0 vicryl, implantation of new life cell stratice mesh, 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: a4, a5a (ethnicity), a5b (patient race), b2, b5, b6, b7, h6 (added patient and imf codes) ime 2402: gas collection, hypoactive bowel sounds, abdominal wall mass, foul smelling urine, sinus tract.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 hernia.It was reported that after implant, the patient experienced adhesions, perforation, abdominal abscess, fistula, infected mesh, defect in the anterior wall of the small bowel, adhesions, serosal defects, open wound, necrotic tissue, purulent material, small bowel obstruction, chronic pain, mesh erosion, ingrown mesh to fistula, light growth enterococcus species, light growth alphahemolytic streptococcus, focal gas collection, fluid collection, inflammation, foreign body reaction, seroma, anastomotic leak, rash, tenderness, fever, chills, nausea, vomiting, bloating/distention, abdominal pain, diarrhea, hypoactive bowel sounds, abdominal wall mass, enterotomies, spillage at colotomy, bloody drainage, foul smelling urine, granulomatous sinus tract, suture granuloma, and ischemic looking bowel.Post-operative treatment required included medication, multiple french drains, repair of colotomy.Exploratory laparotomy, adhesiolysis, small bowel resection with primary anastomosis, wound vac, tube jejunostomy, hernia repair with new mesh, ct scan, admission to hospital, j tube, ng tube, colotomy irrigated/cleaned, and mesh removal.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 8499728
• MDR Text Key: 141470890
• Report Number: 9615742-2019-01171
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179769
• UDI-Public: 10884521179769
• 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: 11/03/2022

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: 03/31/2015
• Device Model Number: PCO2015X
• Device Catalogue Number: PCO2015X
• Device Lot Number: PND0338
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 04/12/2019; 05/15/2019; 05/15/2019; 02/09/2022; 09/07/2022; 10/26/2022
• Supplement Dates FDA Received: 04/17/2019; 10/28/2019; 12/17/2019; 03/09/2022; 09/09/2022; 11/04/2022
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White