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

Device Problems Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Erosion (1750); Fever (1858); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  Injury  

Event Description

The following was reported to gore from the viedoc study database: on (b)(6) 2022 the patient has been treated with a gore® acuseal vascular graft.On (b)(6) 2023 this 71-year-old patient underwent implantation of a gore® viabahn® endoprosthesis with propaten bioactive surface in the left upper arm.There were no adverse events during this procedure.On (b)(6) 2023 the patient was noted to have an infection of the graft and the vsx device.It has been confirmed, that the infection was a systemic bacterial infection and e.Coli, s.Haemoliticus and c.Albican bacterial have been confirmed within a laboratory evaluation.Reportedly on (b)(6) 2023 the patient had a surgical reintervention.The gore® viabahn® endoprosthesis with propaten bioactive surface and the gore® acuseal vascular graft were explanted as part of the reintervention.The patient was discharged home (b)(6) 2023.The devices have been discarded and are not available for evaluation.

Manufacturer Narrative

D10: gore® viabahn® endoprosthesis with propaten bioactive surface.H3: the device has been discarded at the facility.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.

Manufacturer Narrative

Emdr section h6: codes: updated to reflect results of investigation.The reported graft infection is not a serious injury, due to prior cannulation for dialysis.

Event Description

The following was reported to gore, from the viedoc study database: on (b)(6) 2022, the patient has been treated with a gore® acuseal vascular graft.As an av access graft in the left upper arm for hemodialysis, due to renal insufficiency.On (b)(6) 2023, this 71-year-old patient underwent implantation of a gore® viabahn® endoprosthesis with propaten bioactive surface in the left upper arm at the venous anastomosis, because of restenosis of the vascular graft.The gore® acuseal vascular graft was cannulated several times, after the vsx device has been implanted.There were no adverse events, during this procedure.On (b)(6) 2023, the patient came to dialysis with a fever and an exposed vascular graft.Additionally, it was noted, to have an infection of the graft and the vsx device.It has been confirmed, that the infection was a systemic bacterial infection and e.Coli, s.Haemoliticus.And c.Albican bacterial have been confirmed, within a laboratory evaluation.Reportedly, on (b)(6) 2023, the patient had a surgical reintervention.The gore® viabahn® endoprosthesis with propaten bioactive surface.And the gore® acuseal vascular graft were explanted as part of the reintervention.Due to the infection, the patient remained without any vascular access for hemodialysis for 48h.Then a temporary femoral central vein catheter was placed.And later, replaced with a tunneled jugular central vein catheter.The patient was discharged home (b)(6) 2023.The explanted devices were discarded.

Manufacturer Narrative

The information reported to gore indicates that the gore® acuseal vascular graft was used as an arteriovenous access graft for dialysis and was cannulated several times.The reported infection represents a known complication or adverse event that can occur when cannulating grafts combined with stent-graft endovascular devices and can arise as a result of a multitude of factors, including cannulation techniques, post-operative follow-up and treatment regimen and patient-related risk factors.In the instructions for use the following is stated: possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with propaten bioactive surface or in any endovascular procedure and require intervention include, but are not limited to: infection.Therefore the reported event no longer meets the criteria of a reportable incident and will therefore be closed as a non-reportable incident.

Manufacturer Narrative

Emdr section h6 codes have been updated to reflect results of this investigation.This report was initially retracted for device infection as the arteriovenous access graft had been previously cannulated for dialysis.However, further review also indicates graft exposure.Dehiscence is considered a serious injury; therefore, this case remains reportable.

• Brand Name: GORE® ACUSEAL 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18424692
• MDR Text Key: 331783269
• Report Number: 2017233-2024-04517
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/29/2024

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: 12/20/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 12/20/2023; 11/27/2023; 11/27/2023; 11/27/2023
• Supplement Dates FDA Received: 03/14/2024; 04/30/2024; 06/07/2024; 07/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG