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

Model Number PCO9

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Cyst(s) (1800); Purulent Discharge (1812); Fever (1858); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); 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 incisional hernia.It was reported that after the implant, the patient experienced adhesions, hernia recurrence, abscess, infected mesh, mesh erosion, and pus.Post-operative patient treatment included hernia repair with mesh, explant of mesh, drainage of right flank abscess and of complex abdominal wall abscess, small bowel resection, abdominal wall reconstruction, multiple ventral hernia repaired with sutures, and revision surgery.

Manufacturer Narrative

Additional information: a5a, a5b, b5, b6, b7, d6b, h6 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 incisional hernia.It was reported that after the underlay implant, the patient experienced adhesions, hernia recurrence, abscess, pain, scarring, fluid collection, serosal tearing, abdominal wall mass, drainage of sinus, sinus tract, elevated wbc malaise, feverish, giant cell reaction, inflammation, cystic mass, systemic illness, leg suddenly gives out, weak, xanthomatous inflammation, fibrosis, fluid filled mass, propionibacter acnes, tenderness, low wbc, infected mesh, mesh erosion, and pus.Post-operative patient treatment included hernia repair with mesh, explant of mesh, lysis of adhesions, drainage of right flank abscess and of complex abdominal wall abscess, small bowel resection, abdominal wall reconstruction, iliacus fascia, multiple ventral hernia repaired with sutures, antibiotics, and revision surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a incisional hernia.It was reported that after the underlay implant, the patient experienced small bowel obstruction, adhesions, hernia recurrence, abscess, pain, scarring, fluid collection, serosal tearing, abdominal wall mass, drainage of sinus, sinus tract, elevated wbc malaise, feverish, giant cell reaction, inflammation, cystic mass, systemic illness, leg suddenly gives out, weak, xanthomatous inflammation, fibrosis, fluid filled mass, propionibacter acnes, tenderness, low wbc, infected mesh, mesh erosion, and pus.Post-operative patient treatment included hernia repair with mesh, explant of mesh, lysis of adhesions, drainage of right flank abscess and of complex abdominal wall abscess, small bowel resection, abdominal wall reconstruction, iliacus fascia, multiple ventral hernia repaired withsutures, antibiotics, and revision surgery.Relevant tests/laboratory data (b)(6)2012: pathology report from right flank mesh specimen showed surrounding giant cell reaction (4x3 cm) (b)(6) 2014: pathology report from abdominal fat tissue and mesh specimen showed acute and chronic inflammation, xanthomatous inflam mation and fibrosis (b)(6) 2019: per op note, right lower quadrant mass that seemed to be fluid filled on imaging, near tacks.Negative on aspiration x1 for culture per the (b)(6)2019 op note, culture this day grew out propionibacter acnes (b)(6) 2019: per op note, imaging showed focus of tacks near the asis on the right close enough to the surface where there was some tenderness and prior recent infection.Incidental finding of iliacus muscle hernia wheresmall bowel entering into the iliacus muscle through a rent in the iliacus fascia and exiting the abdominal cavity into the upper thigh.(b)(6) 2019: deep wound culture with 1+ wbcs.

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 info: (added patient codes, ime (b)(4): "mass, sinus tract, elevated wbc, low wbc, systemic illness, leg give out, xanthomatous inflammation").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 incisional hernia.It was reported that after the underlay implant, the patient experienced infection, chronic draining open wound, small bowel obstruction, adhesions, hernia recurrence, abscess, pain, scarring, fluid collection, serosal tearing, abdominal wall mass, drainage of sinus, sinus tract, elevated wbc malaise, feverish, giant cell reaction, inflammation, cystic mass, systemic illness, leg suddenly gives out, weak, xanthomatous inflammation, fibrosis, fluid filled mass, propionibacter acnes, tenderness, low wbc, infected mesh, mesh erosion, and pus.Post-operative patient treatment included mesh revision, incision and drainage, wound vac, medication, hernia repair with mesh, explant of mesh, lysis of adhesions, drainage of right flank abscess and of complex abdominal wall abscess, small bowel resection, abdominal wall reconstruction, iliacus fascia, multiple ventral hernia repaired with sutures, antibiotics, and revision surgery.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 12025537
• MDR Text Key: 257265650
• Report Number: 9615742-2021-01478
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• 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: PCO9
• Device Catalogue Number: PCO9
• Device Lot Number: PKD00157
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2022
• 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
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White