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

Model Number	BXA075902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a patient participating in a study received treatment for a thoracoabdominal aortic aneurysm.During treatment, a two 7 x 59 gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were overlapped and implanted in left renal artery.One vbx device was implanted most proximal within the portal and vbx device was implanted as first distal extension.On (b)(6) 2022, patient follow-up surveillance revealed high renal velocities bilaterally and the surveillance ct scan suggested a left renal stenosis distal to the branch.Angiogram revealed no right renal stenosis.On (b)(6) 2022, a reintervention was performed due to the distal left renal artery stenotic lesion.No renal function deterioration was observed.Patient tolerated the procedure.
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.Review of device manufacturing record history confirmed device met pre-release specifications.Device remains implanted; therefore, direct product analysis was not possible.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis hazards and adverse events procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and/or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malpositions; inflammation; and/or death.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; distal embolism; side branch occlusion; vessel wall trauma and/or rupture; false aneurysm; infection; inflammation; fever and/or pain in the absence of infection; deployment failure; migration; and device failure.A possible complication which may occur in conjunction with the use of any heparin-containing product: hit type ii.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
During same procedure / same patient, two gore® viabahn® vbx balloon expandable endoprostheses (device) were overlapped / implanted as one unit in the left renal artery.Device lot/serial # (b)(6); udi # (b)(4) was implanted in most proximal within the portal (renal artery).The second device lot/serial # (b)(6) ; udi # (b)(4) was implanted as a distal extension.It was not clearly specified which of the two devices (same type) was implicated in the reported issue.Review of manufacturing record history confirmed both devices met pre-release specifications.Both devices remain implanted.

• 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: 15567494
• Report Number: 2017233-2022-03388
• Device Sequence Number: 14992130
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 04/17/2024
• Device Model Number: BXA075902A
• Device Catalogue Number: BXA075902A
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White