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

Catalog Number BXA107901J

Device Problem Burst Container or Vessel (1074)

Patient Problem Pain (1994)

Event Date 07/08/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing records were reviewed, and the device met all pre-release specifications.The device remains in the patient.Consequently, a direct product analysis was not possible.The patient¿s external iliac artery was reportedly stenotic, and ballooning was performed with a known risk of rupture as related to patient condition.Gore® viabahn® vbx balloon expandable endoprosthesis instructions for use state; stenotic or occlusive lesions: to reduce the potential for vessel damage, the final stent inner diameter (as indicated on the compliance chart) should approximate the diameter of the vessel just proximal and distal to the stenosis.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2022, a patient underwent endovascular treatment of an aortic dissection using two gore® excluder® aaa endoprostheses, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx), and a gore® viabahn® endoprosthesis with heparin bioactive surface.It was reported the dissection extended down the abdominal aorta from the level of the renal artery level.The distal location of the dissection was unknown.During treatment, a stent was implanted in the left renal artery using a chimney technique to ensure patency.A gore® excluder® iliac extender component was then implanted below the left renal artery due to the true lumen being especially narrow.When removing the iliac extender delivery catheter, the leading olive was reportedly caught on the distal end of the stent graft.The cause of the olive being caught was unknown, however, the physician stated that deploying the stent graft in a narrow portion of the true lumen may have been a contributing factor.According to the report, an attempt was made to remove the catheter with force, and the olive broke off from the catheter.After additional ballooning at the distal end of the stent graft, the olive was successfully removed from the patient.Another gore® excluder® iliac extender component was implanted distally into the right external iliac artery.A 10mm x 79mm gore® vbx device was deployed to extend distally into the right external iliac artery.While ballooning the gore® vbx device, the right external iliac artery was reportedly ruptured.It was reported that patient¿s external iliac artery was stenotic, and ballooning was performed with a known risk of rupture.The patient¿s blood pressure was stabilized using an occlusion balloon.As a planned, a 10mm x 10cm gore® viabahn® device was implanted distally.A final intra-operative angiograph reportedly revealed an endoleak, and a leak from the ruptured area.The physician opted to convert to an open procedure, and the vasculature was surgically repaired.All gore devices remain implanted (further details of the open procedure were not available).The patient tolerated the procedure.

Manufacturer Narrative

Revised h6: added additional investigation conclusion code.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15142312
• MDR Text Key: 297033716
• Report Number: 2017233-2022-03177
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Catalogue Number: BXA107901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female