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

Catalog Number BXA083902A

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

On (b)(6), 2023, a study patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) in the aaa1701 tambe pivotal study.During this treatment, multiple gore® viabahn® vbx balloon expandable endoprosthesis (vbx device(s)) were implanted as side branch devices.The vbx devices were implanted in superior mesenteric artery (sma; 2), left renal artery (3), celiac artery (1) and right renal artery (4).On (b)(6), 2023, cta imaging was performed.Results showed a vbx device that had been implanted in the right renal artery as a distal extension within the portal was found in the aneurysm sac.The report stated the fourth right renal artery side branch component is present, fully deployed, within the aneurysm sac and is not connected to any additional components of the tambe system of devices.It follows the left renal artery side branch component and continues approximately 2cm distal of the left renal artery.Intervention, was not reported and patient appears to be asymptomatic.

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.H6: code: c19: a review of the manufacturing records indicated the device met pre-release specifications.H3: and h6: code: b20: device remains implanted; therefore, direct product analysis was not possible.Images were not made available, but migration was confirmed by third party lab.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

H6 - code b20: the device remains in the patient.A product evaluation was performed with the following results: the primary reported device failure, related to an inability to position the device in the desired location, could not be independently confirmed as no items were returned for evaluation.The physician reportedly withdrew the device and left it in the aneurysm sac where it remains.The cause of the primary reported inability to place the device in the target location could not be established with the available information.B5: event description was updated.

Event Description

On (b)(6), 2023, a male study patient underwent endovascular procedure for a complex thoracoabdominal aneurysm repair using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe).Gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent) were implanted as side branch devices in the superior mesenteric artery (sma), celiac artery (ca), left renal artery (lra), and right renal artery (rra).No issues were reported during the sma and ca vbx stent implants.During the procedure, the tambe device was advanced to appropriate position and partially deployed.The procedure proceeded with some challenges due to the right angle to takeoff of the renal arteries that were selectively catheterized with appropriate wires and sheath.The 0.018 wire was left in place on the left due to significant angulation.Rosen wire was placed into both renal arteries.In the lra, three vbx devices were implanted.A 7 x 59 vbx stent was advanced into portal and deployed.An 8 x 59 vbx stent was deployed more distally and out into the renal vessel.A 7 x 59 bridging stent was implanted due to the impingement area and renal vessel angulation.The deployed vbx stent was ballooned up to 8 mm between the two vbx stents.Significant angulation of the rra required valsalva to catheterize more distally into the vessel.A 7 x 79 vbx stent was positioned proximally into the portal and deployed.Next, an 8 x 59 vbx stent was implanted as first distal into the rra.An 8mm balloon allowed for good apposition between the deployed 7 mm and 8 mm vbx stents.Next, the tambe device was fully deployed to prevent ¿wind socking¿ of the tambe device by the deployment of the final vbx stent.With that, the wire in the right renal had retracted slightly.A separation between the proximal and distal vbx stents in the renal vessel was also noted.Re-catheterization was not possible because of the significant angulation at the right renal vessel.With extra effort, a floppy glidewire was advanced into the distal right renal stent, but a rosen wire could not be tracked into the area.A steerable sheath was able to reach, and the area was catheterized.Using an 8 mm balloon, the physician tried to get the 8 x 39 vbx stent more cranially oriented to allow for implant of a bridging stent.The vbx stent was unable to align appropriately.Consequently, the 8 x 39 vbx stent was extracted from the origin of the rra without injury to the vessel and released into the aneurysm sac.The renal vessel was then re-catheterized.To prevent further migration into the distal aorta and iliac arteries, the ibe components were deployed.Due to the proximity of the tambe device, it was difficult to manipulate and pass the final vbx stent into the rra.The region was ballooned and an 8 x 79 vbx stent was advanced through the portal and into the renal artery and deployed.Completion angiogram revealed excellent flow through all four portal vessels and in the iliac arteries with no evidence of endoleaks.The patient tolerated the procedure.Cta imaging performed on (b)(6) 2023 showed 3 side branch components implanted in the left renal artery and 3 side branch components in the right renal artery.It was confirmed one side branch component was in the aneurysm sac.Patient was asymptomatic and no intervention was performed.

• 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: 19000668
• MDR Text Key: 339118175
• Report Number: 2017233-2024-04768
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2022
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White