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

Catalog Number BXA083901J

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2022, a patient underwent endovascular treatment for thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system (ctag ac) and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).The vbx device was to be implanted from the left common carotid artery into the ctag ac.After the ctag ac was deployed and punctured from the left common carotid artery, ballooning was performed.At this time, the 0.035 x 180cm radifocus¿ stiff terumo guidewire slipped out of place and had to be re-cannulated into position.As the vbx device was delivered through a 7fr x 23cm brite tip® cordis sheath, strong resistance was felt.It was realized the guidewire was between the ctag ac and the patient's vessel wall rather than inside the ctag ac.Attempts were made to pull the vbx device back, but the undeployed stent of the vbx device had dislodged and remained between the ctag ac and the vessel wall.Ballooning was performed to seal and prevent the vbx stent from migrating into the aorta.A new vbx device of the same size was implanted in the intended location, and the procedure was completed with no further issues.The patient did not experience any adverse consequences.

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Patient weight; relevant medical history and medications were requested, but not made available.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis state in hazards and adverse events: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and/or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and/or death.Directions for use: guidewire length should be at least twice the length of the gore® viabahn® vbx balloon expandable endoprosthesis delivery catheter.Be sure to remove the balloon catheter while maintaining the position of the guidewire beyond the target lesion.It is strongly recommended that the guidewire remain across the lesion until the procedure is complete to avoid having to regain access.

Manufacturer Narrative

H6: code 213: the device remains implanted; therefore, direct product analysis was not possible.The engineering evaluation states: the complaint description states that the guidewire was positioned between the gore® tag® conformable thoracic stent graft with active control system (ctag ac) and the patient's vessel wall instead of inside the ctag ac.As a result of the failure to advance the vbx device, withdrawal was attempted.The endoprosthesis of the vbx device dislodged from the delivery catheter and remained between the ctag ac and the vessel wall.The cause of the secondary reported failure mode of endoprosthesis loses retention to the delivery system could not be confirmed with the information provided but appears consistent with interaction between the vbx device and the previously placed ctag ac due to the misplaced guidewire.The manufacturing records were reviewed and documented in the product history task.The device lots met all pre-release specifications.

• 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: 14465620
• MDR Text Key: 292501668
• Report Number: 2017233-2022-02949
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA083901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male