MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC

Model Number 1DLMCP02

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 05/07/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4). The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)]. It should be noted that the gore® dualmesh® plus biomaterial instructions for use 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. ".

Event Description

It was reported to gore that the patient underwent laparoscopic ventral hiatal hernia repair on (b)(6) 2010, (b)(6) 2017, and (b)(6) 2017, whereby gore® dualmesh® plus biomaterial and gore® bio-a® tissue reinforcement were implanted. The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby one of the gore devices were explanted. It was reported the patient alleges the following injuries: removal of gore mesh due to dense erosion and infection, gore mesh was stained throughout due to erosion, foul smell from the infected gore mesh, large portion of the stomach eroded to the gore mesh, gastrectomy due to mesh erosion, portion of gore mesh appeared dark and discolored, dense adhesions noted along the undersurface of the liver, primary repair of recurrent hiatal hernia defect. Additional event specific information was not provided.

• Brand Name: GORE DUALMESH PLUS BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: heidi womble ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11231310
• MDR Text Key: 228728517
• Report Number: 3003910212-2021-01156
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2012
• Device Model Number: 1DLMCP02
• Device Catalogue Number: 1DLMCP02
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2009
• 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: 01/26/2021 Patient Sequence Number: 1