MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBHR110502A

Device Problem Device Stenosis (4066)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

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

On (b)(6) 2023, a patient underwent multiple surgeries due to trauma.A gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was used in the right common iliac artery.On (b)(6) 2023 the patient underwent a relining procedure because the viabahn device had become thrombosed.The device was lined with a gore® excluder® aaa endoprosthesis iliac extender.Reportedly, heparin-induced thrombocytopenia (hit) was suspected by the physician on (b)(6) 2023.The physician did not think the hit was caused by the viabahn device.It was reported the patient is doing fine after the relining procedure.

Manufacturer Narrative

A review of manufacturing and heparin records verified that the lot involved in this complaint met all pre-release specifications.The device remains implanted and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.This complaint was initiated based on information received from the field.No items were available to directly evaluate product performance relative to the reported device failure mode.Moreover, the available information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.The reported device thrombosis represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intraprocedural technical considerations, 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.The physician suspected heparin-induced thrombocytopenia (hit), but did not attribute the response to the device.The suspected adverse event is a possible complication that may occur in conjunction with the use of any heparin-containing product or in conjunction with the use of systemic heparin as indicated in the device ifu, and the device is contraindicated for patients with known heparin sensitivity.However, further information on patient history and confirmation of the hit diagnosis was not provided, and the relationship between the suspected hit and the reported thrombosis could not be established with the available information.The gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail, and there are applicable statements.The ifu states the following: "possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with heparin 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 HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17789712
• MDR Text Key: 323941056
• Report Number: 2017233-2023-04292
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VBHR110502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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): Required Intervention; Other
• Patient Age: 19 YR
• Patient Sex: Female