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

Catalog Number	VBHR101002A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Thrombocytopenia (4431)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2024, a gore® tag® thoracic branch endoprosthesis (tbe) aortic component (ac), gore® tag® conformable thoracic stent graft (ctag), and four gore ® viabahn® (vsx) devices were used to treat a patient that had a congenital coarctation of the aorta, that had led to a 9cm aortic arch aneurysm.The tbe ac was successfully deployed descending thoracic aorta to treat the aneurysm and the vsx devices were placed in the portal of the tbe ac and extended to the left subclavian artery (lsa).The ctag device was used to extend the tbe ac proximally up to the level of the left common carotid artery (lcca).Patient had heparin administered to maintain act above 250 during the index tbe procedure on (b)(6) 2024.The patient tolerated the endovascular procedure.On (b)(6), 2024, the patient received a larger dose of unfractionated heparin during a planned open aortic arch reconstruction.After the operation on (b)(6), the patient experienced a steady decrease in platelet count.The patient had a hit positive test on (b)(6) and the use of heparin was discontinued.Additionally, the patient had left arm superficial venous thrombosis, left ventricular thrombus with cardioembolic stroke to brain following the procedure on (b)(6).On (b)(6), the physician elected to reline the vsx devices and tbe ac portal with non-heparin bonded icast covered stent (9 x 59 mm x 2) and molding angioplasty with 10 mm balloon.The physician stated: heparin-induced thrombocytopenia (hit) positive test (b)(6), 2024, (pf4+, sra+) and no history of hit.The patient has made a full recovery and has no residual symptoms related to the cardioembolic stroke.Patient symptom code 2203-a - other, used to capture the stroke.
Additional 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.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.A review of manufacturing 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.The clinical images enabling direct assessment of product performance were returned for evaluation.Images show the presence of a ctag device and a tbe; vsx stents are also confirmed in the lsa and extends distal to the tbe portal to ¿snorkel" the stents between the aortic devices implanted.There appears to be flow throughout all devices.Cannot confirm stroke information within the description summary.Further information regarding this event was requested by gore, but no further information has been reported, therefore, this investigation is considered complete.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20524141
• Report Number: 2017233-2024-05432
• Device Sequence Number: 9105496
• Product Code: NIP
• UDI-Device Identifier: 00733132646043
• UDI-Public: 00733132646043
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2025
• Device Catalogue Number: VBHR101002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 44 YR
• Patient Sex: Unknown