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

Model Number BXA055902A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 02/13/2023

Event Type  Injury  

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.Devices remain implanted; therefore, direct product analysis was not possible.Code c19: review of device manufacturing record history confirmed both devices met pre-release specifications.Only one report is submitted as two gore® viabahn® vbx balloon expandable endoprostheses (device) were implanted as one unit in the right renal artery in an overlapped fashion.The second device lot/serial number is (b)(4); udi number (b)(4); catalog number bxa073902a.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

On (b)(6) 2022, a study patient underwent endovascular treatment for abdominal aortic aneurysm in the gore® excluder® thoracoabdominal branch endoprosthesis (tambe) clinical trial.The vbx stents were implanted as branch components in the celiac, superior mesenteric artery (sma), left and right renal arteries.During a re-intervention on (b)(6) 2023, pre procedure ct revealed a definitive and unknown iii leak from the right renal vbx stents.On the same day, intervention was performed by re-stenting, and the endoleak was resolved.The patient tolerated the procedure.

Manufacturer Narrative

B4: event description was updated.H6 - code c20: an engineering evaluation was completed.The primary reported issue, a tear in the graft material causing a type iii endoleak, for the device(s), could not be independently confirmed with the available information.Only one type iii endoleak was reported, but with which implanted endoprosthesis the reported complication occurred could not be established so both devices are investigated to the extent possible.Neither clinical images nor the devices were returned for evaluation.The cause for the reported graft tear could not be established with the available information.

Event Description

On *(b)(6) 2022, a study patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm in the gore® excluder® thoracoabdominal branch endoprosthesis (tambe) clinical trial.The vbx stents were implanted as branch components in the celiac, superior mesenteric artery (sma), left and right renal arteries.Two vbx stents were deployed in an overlapped fashion (one unit) in the right renal artery.During another intervention on (b)(6) 2023, ct scans performed pre procedure revealed a definitive and unknown iii leak from the right renal mid vbx stents.As reported, the physician suspected this was due to a graft tear of the vbx stent.On the same day, balloon angioplasty with implant of a 5mm x 59mm vbx device were completed.The patient tolerated the procedure.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16500056
• MDR Text Key: 310852154
• Report Number: 2017233-2023-03781
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637133
• UDI-Public: 00733132637133
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BXA055902A
• Device Catalogue Number: BXA055902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• 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 Age: 84 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White