MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number PAHR090502E

Device Problem Complete Blockage (1094)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 06/22/2023

Event Type  Injury  

Event Description

Patient history included hypercholesterolemia, hypertension, and renal insufficiency requiring hemodialysis since (b)(6) 2020.On (b)(6) 2023, a 6 mm gore vascular graft (not further specified) was implanted as an arterio-venous access graft for hemodialysis in the left upper arm in a straight configuration.On (b)(6) 2023, the gore vascular graft occluded at the venous outflow.The total length of the occlusion was reported to be 80 mm.The lesion was successfully treated with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx device) during an endovascular procedure.During the procedure heparin medication was administered.Reportedly the vsx device was patent at the end of the procedure.On (b)(6) 2023, an access circuit related thrombosis of the vsx device occurred that led to occlusion of the vsx device.On (b)(6) 2023, a repeat intervention was performed, but patency of the vsx device could not be restored endovascularly despite additional heparin administration.Therefore, the vsx device was surgically explanted.No procedural complications were reported.The type of repair of the resulting lesion was not specified.The patient recovered without sequelae and was discharged on (b)(6) 2023.

Manufacturer Narrative

H6-b14: the manufacturing records are being reviewed.H6-b13: a request was emailed to the physician to further clarify the event and the location of the explanted device.H6-b17: the location of the explanted device remains unknown.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.

Manufacturer Narrative

H6-b14 and c19: a review of the manufacturing records indicated the device met pre-release specifications.Section c.Suspect products name: cbas® heparin surface.Manufacturer/compounder: w.L.Gore & associates, inc.

Manufacturer Narrative

Cause investigation and conclusion a review of the manufacturing records indicated the device met pre-release specifications.The information reported in the incident does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.Neither images enabling direct assessment of product performance nor the product itself were returned for evaluation.The reported device occlusion represents a known complication or adverse event that can occur when using stent-graft endovascular devices which can result from several factors including post-operative follow-up and treatment regimen, patient-related risk factors and disease progression.No allegation of device malfunction, such as stent collapse or structural deformation was indicated with respect to device performance.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.No potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: adverse events 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: ¿ occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17324144
• MDR Text Key: 319208732
• Report Number: 2017233-2023-04108
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P130006
• 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,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAHR090502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: UNKNOWN GORE VASCULAR GRAFT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 104 KG