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

Model Number RRT06060080L

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Post Operative Wound Infection (2446)

Event Date 09/19/2014

Event Type  Injury  

Manufacturer Narrative

H6 code b17 and h3-other: the current location of the device is unknown.H6-code b14 and c19: a review of the manufacturing records indicated the lots met all pre-release specifications.H6-code b13: a request was emailed to the study coordinator to further clarify the infection and the reintervention.The answer is pending.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 Description

On (b)(6) 2014, this study subject underwent an endovascular procedure on the right lower limb due to a peripheral artery disease with a gore-tex® vascular graft.The proximal and distal anastomosis were specified to be in the common femoral and popliteal arteries respectively.Reportedly the procedure was uneventful, and the graft was patent at the end of the procedure.The patient was discharged to home on (b)(6) 2014.On (b)(6) 2014, the patient presented with reported adverse event termed "infection of the right femoro-popliteal gore bypass".Reportedly a reintervention was performed (not further specified).The outcome of the adverse event was recorded as resolved without sequelae.

Manufacturer Narrative

Cause investigation and conclusion a review of the manufacturing records indicated the lots met all pre-release specifications.An evaluation of the device allowing direct assessment of product performance could not be performed because the graft remains implanted in the patient.Therefore graft infection could not be independently confirmed based on the available information.However, it is recorded within the study database that, per the assessment of the study site, there is no relationship between the reported infection and the graft or the onset procedure.Based on the event description and the subsequent investigation we are unable to determine the cause of this incident and assign a root cause.In the instructions for use the following is stated: 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: infection;.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17149191
• MDR Text Key: 317447929
• Report Number: 2017233-2023-04029
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132610945
• UDI-Public: 00733132610945
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• 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
• Patient Age: 79 YR
• Patient Sex: Female