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

Model Number PCO9X

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

Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Dehydration (1807); Diarrhea (1811); Purulent Discharge (1812); Gangrene (1873); Gastritis (1874); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Scarring (2061); Septic Shock (2068); Vomiting (2144); Chills (2191); Cramp(s) (2193); Discharge (2225); Hernia (2240); Hypovolemia (2243); Anxiety (2328); Injury (2348); Impaired Healing (2378); Diaphoresis (2452); Sleep Dysfunction (2517); Ascites (2596); Blood Loss (2597); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced abscess, open wound, recurrence, adhesions, mesh migration, infection leading to septic shock, adhesions to bowel, septic shock lead to ischemia of toes, leading to gangrene and foot amputation, fluid collection, pyelonephritis/cystitis, worsening leukocytosis, bacterial infection, inflammation, fibroadipose tissue, hemorrhage, fibrosis, serositis, rigor, abdominal pain, hypotension, diaphoretic, dehydration, hypoperfusion, acute kidney injury, hypovolemia, lactic acidosis, mild rhabdomyolysis, purulent fluid, hematoma, discharge, wound dehiscence, necrosis, gastritis, bleeding, pericarditis, cellulitis, nausea, pain, scarring, vomiting, chills, cramping, insomnia, anxiety, pulmonary embolism, black tarry diarrhea, and osteomyelitis. Post-operative patient treatment included revision surgery, bowel resection, surgeries to clear infection, hernia repair, explantation of mesh, fascial closure, foot amputation, implantation of mesh, antibiotics, admitted to the icu for fluid resuscitation, placement of negative pressure wound vacuum dressing, non-viable tissue removed, scar excision, lysis of adhesions, and wound vac.

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 therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced abscess, open wound, recurrence, adhesions, mesh migration, infection leading to septic shock, adhesions to bowel, septic shock lead to ischemia of toes, leading to gangrene and foot amputation. Post-operative patient treatment included revision surgery, bowel resection, surgeries to clear infection, hernia repair, explantation of mesh, fascial closure, foot amputation, implantation of mesh, and wound vac.

Manufacturer Narrative

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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a hernia repair with mesh. The patient experienced infection leading to septic shock, adhesions to bowel, bowel resection, multiple surgeries to clear infection and repair hernia, septic shock lead to ischemia of toes, leading to gangrene and foot amputation.

• 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
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 6964683
• MDR Text Key: 247064520
• Report Number: 9615742-2017-05566
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Model Number: PCO9X
• Device Catalogue Number: PCO9X
• Device Lot Number: POE0130X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/20/2017 Patient Sequence Number: 1