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

Device Problem Device Stenosis (4066)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

The serial/lot number was requested and is unavailable.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The device was not returned to gore for direct analysis.No images were provided for evaluation.Therefore, an engineering evaluation could not be performed.According to the instruction for use for the gore® propaten® vascular graft, complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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

The following information was reported to gore: on an unknown date, the patient was implanted with a gore® propaten® vascular graft (propaten vascular graft) as a venous-venous shunt for hemodialysis.The procedure date and the device information is unknown.One or two days post implantation, wound exudate was observed from the incision site approximately 1 mm away from the device.Frequent anastomotic stenosis occurred though it was unclear whether the stenosis was caused by the exudate.On february 7, 2024, the patient underwent an endovascular treatment for the anastomotic stenosis using gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).Blood culture test was negative before the procedure.The viabahn device was implanted to repair the stenosis and the wound exudate.The viabahn device was implanted in a site with observed exudate.Symptomatic improvement was observed immediately after implantation.On (b)(6) 2024, purulent drainage was observed.It was confirmed infection at the site of the viabahn device.On (b)(6) 2024, a reintervention was performed and both propaten vascular graft and viabahn device were removed from the patient.Reportedly, there was a risk of infection since the patient had symptoms of exudate.The physician commented that the device placement to the exudate site may have been a mistake.

• Brand Name: GORE® PROPATEN® 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: amy mckeown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18933807
• MDR Text Key: 338030744
• Report Number: 2017233-2024-04723
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/19/2024
• 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): Other
• Patient Age: 86 YR
• Patient Sex: Male