MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Model Number	V06070L
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	08/06/2016
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.An additional information request regarding the adverse event has been sent to the physician.A review of manufacturing records is ongoing.The device could not be evaluated because it remains implanted.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following was reported top gore: on (b)(6) 2016, this patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of end-stage renal disease during which a gore-tex® vascular graft was implanted.According to reports, a left-side humeral-axillary access was configured, the patient survived the procedure, no adverse event was experienced during the procedure and the device was successfully implanted and retained.The patient was later discharged on (b)(6) 2016.Reportedly on (b)(6) 2016, an adverse event termed "graft infection with staphyloccocus aureus méti-s" was identified.A medical intervention was performed.The primary relationship was recorded as device-related.The adverse event resolved on (b)(6) 2016.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15757930
• Report Number: 2017233-2022-03461
• Device Sequence Number: 17701923
• Product Code: DSY
• UDI-Device Identifier: 00733132614042
• UDI-Public: 00733132614042
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K802095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: 05/13/2020
• Device Model Number: V06070L
• Device Catalogue Number: V06070L
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female