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

Model Number BXA077902A

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 06/14/2022

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.A review of the manufacturing records for lot #'s 23452104 and 23452090 indicated the lots met pre-release manufacturing specifications.Due to no device return, an investigation could not be performed.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

The following information was received by gore from the medrio database in regards to tambe clinical study aaa 17-01: on (b)(6) 2021, a patient received treatment for a thoracoabdominal aortic aneurysm with the gore® viabahn® vbx balloon expandable endoprosthesis being implanted within the right renal artery.On (b)(6) 2022, occlusion was observed within the gore® viabahn® vbx balloon expandable endoprosthesis located in the right renal artery.No treatment has been rendered.

Event Description

On (b)(6), 2021, a study patient received treatment for a thoracoabdominal aortic aneurysm.During this procedure, two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were overlapped and implanted within the right renal artery.On (b)(6) 2022, stenosis was observed within the vbx device located in the right renal artery.No intervention was performed.Additional information obtained on september 27, 2022, states there is some intraluminal thrombus present at the distal end of the second right renal artery.No intervention was reported; right renal component was reported as remaining patent.

Manufacturer Narrative

A4 - patient weight was added.B3 - event date was corrected to onset date.B4 - event description was updated with new information.B7 - added patient medical history, including medication.Contact name was updated in section g.H6 codes were updated.

Event Description

On (b)(6) 2021, a patient received treatment for a thoracoabdominal aortic aneurysm.During this procedure, two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were overlapped and implanted within the right renal artery.One vbx device was implanted in the first distal extension ((b)(6); bxa077902a) and the second vbx device was implanted in the most proximal within the portal ((b)(6); bxa077902a).On (b)(6) 2022, stenosis was observed within the vbx device located in the right renal artery.No intervention was reported at the time.Additional information obtained on september 27, 2022: some intraluminal thrombus is present at the distal end of the second right renal artery.No intervention was reported at the time.It was stated the right renal sb component remained patent.Additional information obtained on october 11, 2022: on (b)(6) 2022, an intervention was performed due to stent graft stenosis.Angioplasty and stenting were done.Reintervention on the treated segment reintervention was performed before occlusion to prevent eventual loss of patency.

Manufacturer Narrative

B3 - event description was updated with new information.Patient had an intervention performed due to.

• 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: 15266535
• MDR Text Key: 298319519
• Report Number: 2017233-2022-03252
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• 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,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American