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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 06/30/1998

Event Type  Injury  

Manufacturer Narrative

The device(s) are unavailable, so no product evaluation can be performed.A review of the manufacturing records for the device(s) could not be conducted because the serial numbers remain unknown.Patient mean gender: female.Patient median age: 65 (28-87).Patient id: case number.Event date: study was closed in (b)(6) 1998.The author was contacted in order to get additional information for the reported wound infections with consequent device removal.

Event Description

Within the article ¿surgical repair of incisional ventral hernias: tension-free technique using prosthetic materials (expanded polytetrafluoroethylene gore-tex dual mesh)¿, published by emmanuel chrysos et al, within the journal the americal surgeon, volume 66, july 2000, page 679-682, the article indicates the following: the purpose of the study was to report the results of a tension-free repair technique using expanded polytetrafluoroethylene gore-tex dual mesh (gore-tex soft tissue patch, w.L.Gore and associates inc, flagstaff, az) in patients with primary or recurrent incisional ventral hernias.From june 1995, through june 1998, 52 patients with incisional hernias have undergone this procedure in the clinic.Fourteen of them had recurrent hernias which had been primarily repaired by mayo hernioplasty.Six of the patients had irreducible hernias preoperatively.Twenty-five patients had hernias on midline incisions, and the rest of them had hernias on transverse abdominal incisions.Four of the patients experienced wound infection and were treated by mesh removal.

Manufacturer Narrative

Updated product name from soft tissue patch to dualmesh device.

Manufacturer Narrative

Additional information related to section c: 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)].¿surgical repair of incisional ventral hernias: tension-free technique using prosthetic materials (expanded polytetrafluoroethylene gore-tex dual mesh)¿, published by emmanuel chrysos et al, within the journal the americal surgeon, volume 66, july 2000, page 679-682.Multiple attempts have been made from gore to the complainant over an extended period of time in order to get additional information.As no information related to this complaint has been or will be provided by the complainant, this event will be closed with the information received.

Manufacturer Narrative

Correction of pma/510k number to k992189.

• Brand Name: GORE® DUALMESH® 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: barbara ulrich ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10829376
• MDR Text Key: 215943021
• Report Number: 3003910212-2020-01134
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: K992189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female