MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SOFT TISSUE PATCH; MESH, SURGICAL, POLYMERIC

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event and date of explant are estimated as (b)(6) 2016 (the published date of the article).Date of implant is estimated as (b)(6) 2016 (7 months prior to the date of event).A review of the manufacturing paperwork could not be performed as the lot number was not available.Gore-tex® soft tissue patch is intended for use in reconstruction of hernias and soft tissue deficiencies.The instructions for use of gore-tex® soft tissue patch warns that use of this product in applications other than those indicated has the potential for serious complications.

Event Description

In a review of the following published literature, these findings were noted: title: ¿heavy-ion radiation therapy for local recurrence of rectal cancer: indication and significance of spacer insertion,¿ authors: keichi takahashi, hiroshi matsumoto, yujiro nakayama, et all.Journal: surgery (0016-593x) vol.78 no.13 page1502-1508(2016.12).The article presents the treatment outcomes of the heavy-ion radiation therapy for local recurrence of rectal cancer using gore-tex® sheets.Out of 19 patients treated in the heavy-ion radiation therapy, 17 patients were treated with gore-tex® sheets (mostlikely gore-tex® soft tissue patch).The following complications were reported out of the 17 patients: 4 cases of ileus, 3 cases of infection, 1 case of protrusion of the sheet into small intestine, and the surgical removal of the sheet.************************************ on unknown date, the patient underwent heavy-ion radiation therapy for local recurrence of rectal cancer.A gore-tex® sheet was implanted to prevent bowel perforation from the therapy.On an unknown date (7months post implantation) , the sheet was found protruded in the small bowel.On an unknown date, the partial resection of the small bowel was performed, and the sheet was removed from the patient.The cause of the protrusion is unknown.

• Brand Name: GORE-TEX® SOFT TISSUE PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: kanae rikimaru ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6320100
• MDR Text Key: 67091433
• Report Number: 3003910212-2017-00012
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention