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

Model Number PCO1510X

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); No Code Available (3191); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a laparoscopic repair of incisional hernia.He had revision surgery 5 years and 9 months post-operative.During the revision surgery he had a repair of recurrent ventral hernia, debridement of muscle and/or fascia, implantation of synthetic mesh, removal of foreign body granuloma, peritoneal cavity, peritoneal lavage and removal of suture under anesthesia.The patient experienced pain, mesh shrinkage, mesh migration, and hernia recurrence.

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.Product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced pain, mesh shrinkage, mesh migration, foreign body granuloma, tissue necrosis, fluid collection, diastasis recti, seroma and hernia recurrence.Post-operative patient treatment included revision surgery, repair of ventral hernia, removal of mesh, wound vac, debridement of muscle and/or fascia, implantation of synthetic mesh, removal of foreign body granuloma, peritoneal cavity, peritoneal lavage, drainage of seroma and removal of suture under anesthesia.

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.Product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced pain, mesh shrinkage, mesh migration, foreign body granuloma, tissue necrosis, fluid collection and hernia recurrence.Post-operative patient treatment included revision surgery, repair of ventral hernia, removal of mesh, wound vac, debridement of muscle and/or fascia, implantation of synthetic mesh, removal of foreign body granuloma, peritoneal cavity, peritoneal lavage, diastasis recti, drainage of seroma and removal of suture under anesthesia.

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 Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced pain, mesh shrinkage, mesh migration, foreign body granuloma, fluid collection and hernia recurrence.Post-operative patient treatment included revision surgery, repair of ventral hernia, removal of mesh, wound vac, debridement of muscle and/or fascia, implantation of synthetic mesh, removal of foreign body granuloma, peritoneal cavity, peritoneal lavage, diastasis recti, drainage of seroma, tissue necrosis and removal of suture under anesthesia.

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 Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced pain, mesh shrinkage, mesh migration, foreign body granuloma, and hernia recurrence.Post-operative patient treatment included revision surgery, repair of ventral hernia, removal of mesh, wound vac, debridement of muscle and/or fascia, implantation of synthetic mesh, removal of foreign body granuloma, peritoneal cavity, peritoneal lavage and removal of suture under anesthesia.

Manufacturer Narrative

Additional information: a1, b5, d8, e1 (facility name, street 1, city, region, postal code), g1(mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number).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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced pain, mesh shrinkage, mesh migration, foreign body granuloma, tissue necrosis, fluid collection, diastasis recti, seroma, abdominal pain, infection, and hernia recurrence.Post-operative patient treatment included revision surgery, repair of ventral hernia, removal of mesh, wound vac, debridement of muscle and/or fascia, implantation of synthetic mesh, removal of foreign body granuloma, peritoneal cavity, peritoneal lavage, drainage of seroma and removal of suture under anesthesia.

Manufacturer Narrative

Additional information: b5, b7, g3, h6 h6 patient codes - e2402 (diastasis recti).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 an incisional hernia.It was reported that after implant, the patient experienced pain, mesh shrinkage, mesh migration, foreign body granuloma, tissue necrosis, fluid collection, diastasis recti, seroma, abdominal pain, infection, open wound, and hernia recurrence.Post-operative patient treatment included revision surgery, repair of ventral hernia with mesh, removal of mesh, wound vac, debridement of muscle and/or fascia, implantation of synthetic mesh, removal of foreign body granuloma, peritoneal cavity, peritoneal lavage, drainage of seroma and removal of suture under anesthesia.

• Brand Name: MESH SOFRADIM - PARIETEX OPTIMIZED COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7135142
• MDR Text Key: 95393149
• Report Number: 9615742-2017-06172
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179707
• UDI-Public: 10884521179707
• Combination Product (y/n): N
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: PCO1510X
• Device Catalogue Number: PCO1510X
• Device Lot Number: PLJ00198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABSTACK30 ABSFIXATION DEVICE30TACKS(LOT# N2G0498X)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 104