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

Model Number	BXA077902A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
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.Two gore® viabahn® vbx balloon expandable endoprosthesis (devices) were implanted in the left renal artery as one unit (overlapped).L/s #25785472 catalog #bxa073902a; udi# (b)(4) (distal extension) and l/s# 25797879 (most proximal).Therefore, one manufacturing report is submitted for same family type devices.B20: both devices remain implanted; therefore, direct product analysis was not possible.C19: review of device manufacturing record history confirmed both devices met pre-release specifications.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis state: device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion.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) 2022, a study patient underwent an aaa procedure.During this procedure, multiple gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent) were implanted in the celiac, right and left renal arteries.On (b)(6) 2023, the patient presented with vbx stent stenosis.As reported, the stenosis was present in both renal arteries.Intervention was performed with balloon angioplasty and non-gore stents were implanted in both renal arteries to reline the existing vbx stents.As stated, the reintervention was performed in the treated segments to prevent eventual loss of patency.The patient recovered well following the intervention.
Additional Manufacturer Narrative
E1 - facility name was added.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17261145
• Report Number: 2017233-2023-04073
• Device Sequence Number: 7882168
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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 Expiration Date: 09/11/2025
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White