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

Catalog Number BXA067902E

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

Event Date 08/22/2023

Event Type  Injury  

Event Description

The following was reported to gore: on or about (b)(6) 2019, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted in the right renal artery as one of the four branch devices during a thoraco-abdominal aneurysm procedure.A patient follow-up was done on (b)(6) 2023.At t his time a control cta was performed, and a type 3-b endoleak was observed.On (b)(6) 2023, the observed endoleak was excluded with an implant of a new 6mm x 59mm vbx device.As reported, the outcome was successful and the patient was doing well following 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.A4: patient weight was requested but not made available.B7: patient relevant medical history and medication information was requested but not made available.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: the device remains implanted.Therefore, direct product analysis was not possible.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.

Manufacturer Narrative

B5: description was updated with correct implant date.D6a: implant date was corrected.

Event Description

On (b)(6), 2019, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted in the right renal artery as one of the four branch devices during treatment of a thoraco-abdominal aneurysm.During a follow-up on (b)(6) 2023, a control cta was performed, and a type 3b endoleak was noted.On (b)(6) 2023, the observed endoleak was excluded with an implant of a 6mm x 59mm vbx device.The outcome was successful and the patient was reported to be doing well following 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: 18352145
• MDR Text Key: 330812847
• Report Number: 2017233-2023-04482
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: BXA067902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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: 73 YR
• Patient Sex: Female