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

Model Number	PCO2H1
Medical Device Problem Codes	Material Erosion (1214); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Perforation (2001); Vomiting (2144); Hernia (2240); Injury (2348); Blood Loss (2597); 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
(b)(4).(recurrence, invasive diagnostic tests and mesh removal surgery) to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was 4 cm hiatal hernia with lerd.The procedure performed was ­­­­­­­­­laparoscopic reduction of hiatal hernia with repair mesh and with endoscopic fundoplication.The patient has had pain, adhesions, recurrence, invasive diagnostic tests, mesh eroded into esophagus and stomach, nausea, vomiting, diarrhea and mesh removal 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.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 laparoscopic reduction of hiatal hernia.It was reported that after implant, the patient experienced recurrence, pain, adhesions, mesh eroded into esophagus and stomach, nausea, vomiting, diarrhea, mesh migration, upper gi bleeding, inflamed membranous fibroadipose connective tissue with focal squamous epithelial lining and ¿sulfur granules¿ consistent with actinomyces organisms, and dysphagia.Post-operative patient treatment included revision surgery, repair of hiatal hernia, explant of eroded mesh, dor fundoplication, gastrostomy tube, upper flexible endoscopy.
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.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 laparoscopic reduction of hiatal hernia.It was reported that after implant, the patient experienced recurrence, pain, adhesions, mesh eroded into esophagus and stomach, nausea, vomiting, diarrhea, mesh migration, and upper gi bleeding.Post-operative patient treatment included revision surgery, repair of hiatal hernia, explant of eroded mesh, dor fundoplication, gastrostomy tube, upper flexible endoscopy.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of laparoscopic reduction of hiatal hernia.It was reported that after implant, the patient experienced recurrence, pain, adhesions, mesh eroded into esophagus and stomach, nausea, vomiting, diarrhea, mesh migration, upper gi bleeding, inflamed membranous fibroadipose connective tissue with focal squamous epithelial lining and ¿sulfur granules¿ consistent with actinomyces organisms, infection, abscess, and dysphagia.Post-operative patient treatment included revision surgery, repair of hiatal hernia, explant of eroded mesh, dor fundoplication, gastrostomy tube, upper flexible endoscopy.
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.
Additional Manufacturer Narrative
Additional information: b5, b7, h6 (patient 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 therapeutic treatment of laparoscopic reduction of hiatal hernia.It was reported that after implant, the patient experienced hematoma, perforation, recurrence, pain, adhesions, mesh eroded into esophagus and stomach, nausea, vomiting, diarrhea, mesh migration, upper gi bleeding, inflamed membranous fibroadipose connective tissue with focal squamous epithelial lining and ¿sulfur granules¿ consistent with actinomyces organisms, infection, abscess, and dysphagia.Post-operative patient treatment included revision surgery, repair of hiatal hernia, explant of eroded mesh, dor fundoplication, gastrostomy tube, edg with biopsy, laparoscopic cholecystectomy, esophageal dilation, medication, upper flexible endoscopy.Relevant tests/laboratory data: (b)(6) 2016: surgical pathology reports inflamed membranous fibroadipose connective tissue with focal squamous epithelial lining and ¿sulfur granules,¿ consistent with actinomyces organisms.Addendum on (b)(6) 2016 for gram positive, silver positive filamentous bacteria consistent with actinomyces species.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 7053116
• Report Number: 9615742-2017-05822
• Device Sequence Number: 1069292
• Product Code: FTL
• UDI-Device Identifier: 10884521178458
• UDI-Public: 10884521178458
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• 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,Followup
• Report Date (Section B): 10/02/2023

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: 03/30/2017
• Device Model Number: PCO2H1
• Device Catalogue Number: PCO2H1
• Device Lot Number: PMC00482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 05/15/2019; 05/15/2019; 11/17/2021; 09/27/2023
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 10/28/2019; 12/18/2019; 12/07/2021; 10/02/2023
• Date Device Manufactured: 04/02/2012
• 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: ABSTACK15(LOT#: N2G0163X).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 62 KG