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

Model Number	BXA052902A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
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.Patient age/dob; gender; weight and relevant medical history, including medications, were requested but not made available.Devices remain implanted.Therefore, direct product analysis was not possible.Two gore® viabahn® vbx balloon expandable endoprosthesis (serial #(b)(4) and (b)(4); both had catalog # bxa052902a).It is unknown which device was implanted in right or left renal artery.Two medwatch reports will be submitted for same procedure / same patient.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis warnings section state: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Do not exceed the maximum rated burst pressure.Exceeding this pressure increases the potential for balloon rupture and possible vessel damage.
Event or Problem Description
The following was reported to gore: during a four-vessel endovascular fenestrated aortic aneurysm repair, two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were utilized.The vbx devices were deployed in the right and left renal artery.As reported, the physician stated the renal arteries were small (less than 5mm) and the vbx balloons were inflated too quickly and were expanded too large, beyond the vessel sizes.Extravasation was seen on angiography.As reported, neither artery could not be saved, resulting in coverage of the fenestration.The vbx devices remain implanted.As reported, the patient was recovering well following the procedure.
Additional Manufacturer Narrative
H6 - code 213: review of device manufacturing record history confirmed device met pre-release specifications.The two gore® viabahn® vbx balloon expandable endoprostheses utilized in this procedure remain implanted.As a result, direct product analysis cannot be conducted.Report # 2017233-2021-02595 was submitted for the second device.
Event or Problem Description
The following was reported to gore: during a four-vessel endovascular fenestrated aortic aneurysm repair with a cook aaa device, two 5mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were utilized.The vbx devices were deployed in the right and left renal artery.As reported, the physician stated the renal arteries were small (approximately 4mm) and the vbx balloons were inflated too quickly and were expanded too large for the vessel sizes.Extravasation was seen on angiography.The physician attempted to salvage the arteries by gaining wire access to visceral vessels.However, neither artery could not be saved, resulting in coverage of the fenestration.The vbx devices remain implanted.The patient was reported to be recovering well following the procedure.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12941248
• Report Number: 2017233-2021-02596
• Device Sequence Number: 4956006
• Product Code: PRL
• UDI-Device Identifier: 00733132637430
• UDI-Public: 00733132637430
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2024
• Device Model Number: BXA052902A
• Device Catalogue Number: BXA052902A
• 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: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown