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

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Hematoma (1884)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided. Therefore, the patient initials reflect the w. L. Gore internal case number. No patient specific information regarding the reported events and interventions was provided in the article. The mean age among the patients in the kh group was reported to 69 years where the majority of the patents are male. The date of incident is unknown. Therefore, the online publication date of the literature article is used as date of incident. 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)]. Email of the initial reporter: (b)(6). Review of the manufacturing records could not be performed as a valid lot number was not provided. Engineering evaluation could not be performed as the device was not returned. (b)(4). Literature citation: bertoglio, c. , morini, l. , maspero, m. , zironda, a. , alampi, b. , mazzola, m. , magistro, c. And ferrari, g. (2021). ¿from keyhole to sandwich: change in laparoscopic repair of parastomal hernias at a single centre¿, surgical endoscopy, 35, pp. 1863¿1871.

Event Description

The following literature article was reviewed: bertoglio, c. , morini, l. , maspero, m. , zironda, a. , alampi, b. , mazzola, m. , magistro, c. And ferrari, g. (2021). ¿from keyhole to sandwich: change in laparoscopic repair of parastomal hernias at a single centre¿, surgical endoscopy, 35, pp. 1863¿1871. This study describes postoperative outcomes for different parastomal hernia (psh) repair techniques. Between january 2004 and december 2018, a consecutive series of 32 patients presenting with psh were treated laparoscopically at niguarda general hospital, milan, italy. Out of these, 19 patients were treated with keyhole (kh) repair using gore® dualmesh® plus biomaterial during january 2004 and october 2014. The following serious incidents were reported by the article: one patients had short-term (30 days) complication of parietal hematoma treated with embolization of the epigastric artery, one patient had long-term (1 year postoperative) complication with bowel perforation of the stoma loop following mesh erosion 3 years after kh repair, which required resection of the stoma loop, mesh removal and fashioning of a new stoma.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12922701
• MDR Text Key: 281653886
• Report Number: 3003910212-2021-01317
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 12/03/2021 Patient Sequence Number: 1