MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8K10A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The exact date of event is unknown, therefore, the online publication date was used as date of event.Per gore-tex® suture instructions for use (ifu), possible adverse reactions associated with the use of any suture include, but are not limited to, tissue dehiscence, infection, localized inflammatory reaction, and transitory local irritation.Broken needles or damaged thread may result in extended or additional surgery or retained foreign bodies.
Event or Problem Description
The following literature article was reviewed: muth, d.R., wolf, a., kreutzer, t., shajari, m., vounotrypidis, e., priglinger, s.And mayer, w.J.(2021).'safety and efficacy of current sclera fixation methods for intraocular lenses and literature overview', klin monbl augenheilkd, 238(8), pp.868-874.This article evaluates the 3 currently most common techniques for intraocular lens (iol) scleral fixation.The 4-point gore-tex® suture technique being one of them.Enrolled in the study were 51 patients with a total of 55 eyes with scleral iol fixation between january 2014 and september 2019.The intrascleral fixation by gore-tex® suture (cv-8) was performed in 14 eyes (total of 12 patients).Two of these eyes required refixation, one of them due to the patient having a re-dislocation of his iol due to rupture of the suture.

• Brand Name: GORE-TEX® SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 15127980
• Report Number: 3003910212-2022-01389
• Device Sequence Number: 20489627
• Product Code: GAW
• UDI-Device Identifier: 00733132604722
• UDI-Public: 00733132604722
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 8K10A
• Device Catalogue Number: 8K10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male