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

Catalog Number BXA115902E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Aneurysm (1708); Ruptured Aneurysm (4436); Insufficient Information (4580)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.No answer has yet been provided by the hospital.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

It was reported to gore that the patient presented with a superior mesenteric artery aneurysm and other medical issues.The measured diameter of the superior mesenteric artery was 13 mm and the physician tried to treat this aneurysm with an 11 mm diameter gore® viabahn® vbx balloon expandable endoprosthesis.On (b)(6) 2022, it was reported that the gore® viabahn® vbx balloon expandable endoprosthesis migrated back into the aorta because the artery was too wide to support it and for its removal, a new open surgical reintervention is being considered.The physician believes that the cause of the issue is the undersizing of the vbx stent compared to the artery.Based on the recent information, it was reported that the male patient was admitted due to pseudoaneurysm of the superior mesenteric artery which was in contact with the patient's duodenum thus leading to infection and sepsis.The initial plan was for the patient to undergo surgery to replace his superior mesenteric artery with an autologous graft at a later date.However the physician thought it would be a good idea to try and control bleeding of this pseudoaneurysm with a vbx stent until this surgical replacement of the superior mesenteric artery with an autologous graft will be conducted.The superior mesenteric artery measurement was confirmed to be 13mm at the ostium and it descended at an angle of 180 degrees.After deployment of the vbx into the superior mesenteric artery, it was reported that due to lack of apposition, the ostium moved slightly into the aorta once the balloon was removed from the stent.Following the planned surgical replacement of the superior mesenteric artery with an autologous graft, the vbx was removed after fulfilling its medical purpose as was initially intended by the physician.According to report, the patient is alive and still recovering.

• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14998261
• MDR Text Key: 295770576
• Report Number: 2017233-2022-03117
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA115902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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): Required Intervention
• Patient Sex: Male