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

Device Problems Deformation Due to Compressive Stress (2889); Device Stenosis (4066)

Patient Problem Ruptured Aneurysm (4436)

Event Date 03/09/2023

Event Type  Injury  

Manufacturer Narrative

Device lot/serial information could not be obtained.Therefore, no manufacturing evaluation could be performed.The device remains in the patient.Consequently, a direct product analysis was not possible.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.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

A literature article titled ¿a case of ruptured juxtarenal abdominal aortic aneurysm treated with double chimney evar¿ was published in march 9, 2023, journal of japanese society for abdominal emergency medicine 2023:43(2) p.413, by masanori hayashi md, et al.Case report: an 80-year-old man who had an asymptomatic ruptured fitzgerad type 1 juxtarenal abdominal aortic aneurysm (jr-aaa) that was found on an incidental contrast-enhanced ct scan.Considering the patient's age and the invasive nature of the surgery, emergency evar was selected, and since the neck was not present due to jr-aaa, double chimney evar was performed to preserve the renal artery.After the non-gore aorta stent graft was deployed, gore® viabahn® vbx balloon expandable endoprosthesis(vbx) were deployed in the bilateral renal arteries and touch up ballooning was performed.The procedure was completed without any issue.The day after surgery, renal function worsened, and a ct angiography showed wedge occlusion at the entrance of the right vbx device, so emergency evt was performed.After aspiration of the thrombus, a bare stent was placed proximal side of the vbx device, and blood flow was restored.The patient was discharged from the hospital on the 8th postoperative day.One and a half years have passed since the surgery and the patient is doing well.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17153441
• MDR Text Key: 317529394
• Report Number: 2017233-2023-04034
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• 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): Hospitalization; Other
• Patient Age: 80 YR
• Patient Sex: Male