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

Model Number	TET2020
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Perforation (2001); Scar Tissue (2060); Hernia (2240); Injury (2348); Ascites (2596); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent left inguinal hernia.It was reported that after implant, the patient experienced recurrence, pain, infection, extensive adhesions, abdominal pain, fluid collection in left lower quadrant at site of hernia repair, intra-abdominal abscess with infection, diverticulitis/inflammation on the sigmoid colon, purulent material between the mesh and colon, sigmoid colon with significant inflammatory changes.Post-operative patient treatment included revision surgery.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent left inguinal hernia.It was reported that after implant, the patient experienced recurrence, pain, infection, extensive adhesions, abdominal pain, fluid collection in left lower quadrant at site of hernia repair, intra-abdominal abscess with infection, diverticulitis/inflammation on the sigmoid colon, purulent material between the mesh and colon, sigmoid colon with significant inflammatory changes, and mesh migration.Post-operative patient treatment included revision surgery, repair of recurrent left inguinal hernia using laparoscopic technique including removal of cord lipoma, laparoscopic exam with aspiration of fluid from left lower quadrant for culture, conversion to open exploratory laparotomy with removal of left lower quadrant mesh including recently placed mesh and also removal of previously placed mesh product, exploration of the sigmoid colon and resection of the sigmoid colon with low anterior colon resection, and left subclavian central line placement.Relevant tests/laboratory data: (b)(6) 2018: cultures from left lower quadrant fluid collection showed enterococcus species.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after implant, the patient experienced recurrence, pain, infection, extensive adhesions, lipoma, abdominal pain, fluid collection at site of hernia repair (fluid relatively serosanguinous), abscess with infection, diverticul itis/inflammation on the sigmoid colon, purulent material, sigmoid colon with significant inflammatory changes, necrosis, scarring, and mesh migration.Post-operative patient treatment included revision surgery, lysis of adhesions, repair of recurrent left inguinal hernia with mesh, removal of cord lipoma, laparoscopic exam with aspiration of fluid for culture, conversion to open exploratory laparotomy with removal of mesh, exploration of the sigmoid colon and resection of the sigmoid colon, open repair of hernia, and left subclavian central line placement.
Additional Manufacturer Narrative
Additional information: a4, b5, b7, h6(patient codes, device codes), additional codes.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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after implant, the patient experienced recurrence, pain, infection, extensive adhesions, lipoma, abdominal pain, fluid collection at site of hernia repair (fluid relatively serosanguinous), abscess with infection, diverticuli itis/inflammation on the sigmoid colon, purulent material, sigmoid colon with significant inflammatory changes, necrosis, scarring, perforation, and mesh migration.Post-operative patient treatment included revision surgery, lysis of adhesions, repair of recurrent left inguinal hernia with mesh, removal of cord lipoma, laparoscopic exam with aspiration of fluid for culture, conversion to open exploratory laparotomy with removal of mesh, exploration of the sigmoid colon and resection of the sigmoid colon, cord lipoma removal, open repair of hernia, medication, and left subclavian central line placement.Relevant tests/laboratory data: (b)(6) 2018: cultures from left lower quadrant fluid collection showed enterococcus species.(b)(6) 2018: pathology report from left inguinal mesh and tissue specimen showed dense acute inflammation and fat necrosis.

• Brand Name: PARIETEX
• Common Device Name: 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: 8487225
• Report Number: 9615742-2019-01036
• Device Sequence Number: 1883996
• Product Code: FTL
• UDI-Device Identifier: 10884521180352
• UDI-Public: 10884521180352
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: TET2020
• Device Catalogue Number: TET2020
• Device Lot Number: SQE0538X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/15/2019; 04/14/2021; 11/22/2023
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 10/17/2019; 04/30/2021; 11/28/2023
• Date Device Manufactured: 06/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABSTACK30 LOT NUMBER: N6B0255EMX; ABSTACK30 LOT NUMBER: N6B0255EMX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG