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

Model Number PCO1510OS

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Death (1802); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Sepsis (2067); Vomiting (2144); Hernia (2240); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Depression (2361); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Constipation (3274); Respiratory Insufficiency (4462); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

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.It was reported that after a procedure where this device was implanted, the patient experienced bowel obstruction; bowel perforation; bowel resection; attempted mesh removal surgery; sepsis; nerve damage; loss of muscle control; death.No information has been provided at this time in regards to the date of death and cause.After the original procedure, additional potentially related procedures were performed, including removal surgery.

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 incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced bowel obstruction, small bowel perforation secondary to the bowel obstruction, infection, fistula, sepsis, abscess, necrosis, inflammation, nerve damage, open wound with difficult healing, dense adhesions, loss of abdominal domain, significant soft tissue edema, bowel edema that prohibited primary closure by component separation, mesh migration, loss of muscle control, diagnosed with c difficile with increasing nausea and vomiting, recurrence, developed abdominal compartment syndrome with increasing hypotension, oliguria, distended abdomen, murky fluid from intraperitoneal cavity, and fibrinous exudate within abdomen.Post-operative treatment required included multiple exploratory laparotomies with lysis of adhesions, small bowel resection, primary small bowel anastomosis, multiple abdominal washouts, component separation and closure, abdominal debridement, multiple wound vac placements, placement of a right arterial line, right chest tube thoracostomy bowel resection, mesh removal/removal surgery, and wound closure surgery.Information received indicates the patient has deceased due to multiple organ failure.No information was provided regarding the association of the circumstances of expiration with this device.

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 incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced small bowel perforation secondary to bowel obstruction, infection, fistula, sepsis, abscess, necrosis, inflammation, nerve damage, open wound with difficult healing, dense adhesions, loss of abdominal domain, significant soft tissue edema, bowel edema that prohibited primary closure by component separation, mesh migration, loss of muscle control, diagnosed with c difficile with increasing nausea and vomiting, recurrence, developed abdominal compartment syndrome with increasing hypotension, oliguria, distended abdomen, murky fluid from intraperitoneal cavity, injury, mental anguish, pain, abdominal pain, constipation, multiple organ failure, respiratory distress, failure of mesh, mesh erosion, dehiscence, damage, defective mesh, disability, disfigurement, loss in capacity to enjoy life, depression, psychological stress, fibrinous exudate within the abdomen, shortened life expectancy, and death.Post-operative treatment required included multiple exploratory laparotomies with lysis of adhesions, small bowel resection, primary small bowel anastomosis, multiple abdominal washouts, component separation and closure, abdominal debridement, multiple wound vac placements, placement of a right arterial line, right chest tube thoracostomy bowel resection, mesh removal/ removal surgery, hospitalization, and wound closure surgery.Information received indicates the patient has deceased due to multiple organ failure.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced small bowel perforation secondary to bowel obstruction, infection, fistula, sepsis, abscess, necrosis, inflammation, nerve damage, open wound with difficult healing, dense adhesions, loss of abdominal domain, significant soft tissue edema, bowel edema that prohibited primary closure by component separation, mesh migration, loss of muscle control, diagnosed with c difficile with increasing nausea and vomiting, recurrence, developed abdominal compartment syndrome with increasing hypotension, oliguria, distended abdomen, murky fluid from intraperitoneal cavity, injury, mental anguish, pain, abdominal pain, constipation, multiple organ failure, respiratory distress, failure of mesh, mesh erosion, dehiscence, damage, defective mesh, disability, disfigurement, loss in capacity to enjoy life, depression, psychological stress, fibrinous exudate within the abdomen, shortened life expectancy, and death.Post-operative treatment required included multiple exploratory laparotomies with lysis of adhesions, small bowel resection, primary small bowel anastomosis, multiple abdominal washouts, component separation and closure, abdominal debridement, multiple wound vac placements, placement of a right arterial line, right chest tube thoracostomy bowel resection, mesh removal/removal surgery, hospitalization, and wound closure surgery.Information received indicates the patient has deceased due to multiple organ failure and respiratory distress.

Manufacturer Narrative

Additional information: g3, g1 (mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number).Correction: b5, d6a (implanted date).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.

• 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
• MDR Report Key: 7533448
• MDR Text Key: 108891346
• Report Number: 9615742-2018-01178
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/15/2021

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 Model Number: PCO1510OS
• Device Catalogue Number: PCO1510OS
• Device Lot Number: PH600051
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/15/2019; 04/07/2021; 06/17/2021
• Supplement Dates FDA Received: 06/13/2019; 05/03/2021; 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention; Disability
• Patient Age: 39 YR