MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL; MULTIPURPOSE SURGICAL MESH, SYNTHETIC POLYMER, NON-BIOABSORBABLE, ANTIMICROBIAL

Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/13/2005

Event Type  Injury  

Manufacturer Narrative

Patient information was requested, but not provided.Additionally, event information such as item/lot number, implant date, date of explant, patient medical history were requested, however no information has been received.According to the instructions for use (ifu) for gore® dualmesh® biomaterial complications may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation,perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.

Event Description

The following literature article was reviewed, "laparoscopic ventral hernia repair with the gore-tex dualmesh: long-term results and review of the literature." the article reports 146 patients had a laparoscopic ventral hernia repair using intraperitoneal gore® dualmesh® biomaterial with a 3-5 cm mesh overlap secured with a combination of non absorbable sutures and staples.It was reported that one patient developed an infection that required removal of the device.

Manufacturer Narrative

Additional device codes added.Updated d1.Brand name.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.

• Brand Name: GORE DUALMESH PLUS BIOMATERIAL
• Type of Device: MULTIPURPOSE SURGICAL MESH, SYNTHETIC POLYMER, NON-BIOABSORBABLE, ANTIMICROBIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9648976
• MDR Text Key: 189996765
• Report Number: 3003910212-2020-00007
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K992189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other