MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number	BXA117901A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the device is unknown which device or devices may have contributed to the reportable event, this report should also include gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices: (b)(6) - bxa087901a (b)(4).Manufactured date: 30-nov-2019 expiration date: 27-nov-2022.(b)(6) - bxa077901a (b)(4) manufactured date: 13-jul-2019 expiration date: 12-jul-2022.A review of manufacturing records (all three vbx devices) verified that the lots involved in this complaint met all pre-release specifications.The information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and / or labeling issue has occurred.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 or Problem Description
On (b)(6) 2020, the patient underwent a covered endovascular reconstruction of the aortic bifurcation (cerab) procedure using gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices.During the procedure, vascular access was obtained via bilateral femoral arteries using a percutaneous approach.It was reported, no access closure device was utilized; manual pressure was applied.Postoperatively, while in the post-anesthesia care unit (pacu), the patient was noted to have an expanding right groin hematoma, suspected to be due to lack of hemostasis at the arterial puncture site.The patient was taken back to the operating room for further management.An unplanned surgical cutdown was performed with right groin exploration.The hematoma was surgically evacuated, and the artery was repaired with primary repair.Following the procedure, the groin hematoma resolved.On (b)(6) 2020, the patient was discharged home.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• 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 nackardp ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25143033
• Report Number: 2017233-2026-07478
• Device Sequence Number: 15815939
• Product Code: PRL
• UDI-Device Identifier: 00733132637751
• UDI-Public: (01)00733132637751(17)220928
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 09/28/2022
• Device Catalogue Number: BXA117901A
• 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: 01/30/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2019
• 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: Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White