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

Model Number	BXA113902A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: gestational renal aneurysm and common iliac artery aneurysm.The instructions for use (ifu) for the gore® viabahn® vbx balloon expandable endoprosthesis states; always use an appropriately sized sheath for the implant procedure.It is advisable to use a sheath or guide catheter that is long enough to cross the lesion.Use of a guide sheath or guide catheter minimizes the risk of dislodging the endoprosthesis from the balloon during tracking.
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm and bilateral common iliac artery aneurysms.A zenith fenestrated endovascular stent graft (zfen device) was implanted just distal to the renal arteries and gore® excluder® iliac branch endoprostheses (ibe devices) were implanted to extend coverage of the zfen device and treat the left common iliac artery aneurysm (lciaa).The right common iliac artery aneurysm was not treated at this time.On (b)(6) 2019, the patient underwent endovascular treatment, and additional ibe devices were implanted to extend coverage of the zfen device and treat the right common iliac artery aneurysm (rciaa).The patient tolerated the procedure.On (b)(6) 2021, the patient underwent reintervention for a suspected type iii endoleak at the junction of the ibe devices and extend coverage within the left hypogastric artery.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was advanced via brachial access hold for anika 3.8 through a 8fr x 45cm terumo sheath.The physician experienced difficulties due to tortuosity and the length of the sheath and the device had was unable to advance over the bend of the subclavian arch and was removed.When the catheter was removed from the patient it was noticed that the vbx device had become dislodged from the balloon and could be visualized resting at the level of the left subclavian artery.The physician was able to advance the same catheter through the device, inflate to 3atm and successfully advance the vbx device to the treatment site.The vbx device was successfully deployed to reline the overlap junction of the ibe devices and extend coverage within the hypogastric artery.The patient tolerated the procedure with no adverse consequences.No type iii endolak was confirmed and not aneurysm enlargement was reported.The physician remarked that the short length of the introducer sheath used, contributed to the difficulties.
Additional 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.H6: component code 515 added h10: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Additional Manufacturer Narrative
G4: corrected pma/510(k)number.
Additional Manufacturer Narrative
G3: corrected date gore aware.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11396542
• Report Number: 2017233-2021-01717
• Device Sequence Number: 13744435
• Product Code: PRL
• UDI-Device Identifier: 00733132637720
• UDI-Public: 00733132637720
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: BXA113902A
• Device Catalogue Number: BXA113902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 01/21/2022; 01/25/2022; 02/09/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 01/21/2022; 01/25/2022; 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male