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

Model Number	RRT06060080L
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	08/21/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 and a4: patient dob and weight were not made available.H6 - code b20: the device remains implanted; therefore, direct product analysis was not possible.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.Ifu for gore-tex® vascular grafts state: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis.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
On (b)(6) 2014, a study patient was implanted with a gore-tex® vascular graft (registry device) due to occlusive disease.The registry device was implanted from the right common femoral artery to the popliteal artery (below knee).On (b)(6) 2014, the patient presented with thrombus at the proximal anastomosis, the right iliac artery and right profunda.A procedure-related acute hemorrhage at the needle-puncture site of the right femoro-popliteal bypass was also observed on the same day.On (b)(6) 2014, an open repair was performed with adjunctive devices.Device patency was restored at end of the procedure.The reported issue of thrombus was resolved without sequelae.The patient tolerated the procedure.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.According to gore-tex® vascular grafts instructions for use, possible complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis.Emdr section h6 codes updated to reflect results of investigation.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17232498
• Report Number: 2017233-2023-04074
• Device Sequence Number: 7241497
• Product Code: DSY
• UDI-Device Identifier: 00733132610945
• UDI-Public: 00733132610945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K880167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 12/18/2023

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: 04/27/2019
• Device Model Number: RRT06060080L
• Device Catalogue Number: RRT06060080L
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• 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: 79 YR
• Patient Sex: Female