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

Model Number BXA087902A

Device Problems Material Perforation (2205); Appropriate Term/Code Not Available (3191)

Event Date 12/30/2022

Event Type  Injury  

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.During patient follow-up visit on (b)(6) 2022, cta showed a brisk endoleak, which looked to be associated with vbx stent in the sma and likely represented a type 1c as there was little extension of the vbx stent into the sma.As reported, the physician stated this was a definitive leak from the vbx mid stent, suspected to be from a fabric tear of the vbx stent.Patient returned for treatment on (b)(6) 2023.Angiographic findings showed no endoleak demonstrated in the sma.However, given the minimal stent overlap into the sma, the vbx stent was extended with a 7x 59mm gore® viabahn® vbx balloon expandable endoprosthesis.Completion arteriogram demonstrated no leak.The endoleak was considered resolved.The patient tolerated the procedure.

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.Device evaluated by mfr: the devices remain implanted.Therefore, direct product analysis was not possible.Adverse event problem - code c19: review of device manufacturing record history confirmed device met pre-release specifications.Adverse event problem - code a27: as reported, there was little extension of the vbx stent into the sma.Consequently, another vbx stent was implanted in the sma as extension during the intervention.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.

• 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: 16453315
• MDR Text Key: 310353135
• Report Number: 2017233-2023-03759
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637799
• UDI-Public: 00733132637799
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BXA087902A
• Device Catalogue Number: BXA087902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Date Device Manufactured: 08/21/2022
• 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): Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White