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

Model Number	BXA073902A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is not known which device or both became occluded, the following additional device was also investigated: sn# (b)(4), udi: (b)(4).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.
Event or Problem Description
On (b)(6) 2020 a patient underwent aortic aneurysm treatment within the (b)(6) clinical study.Two gore® viabahn® vbx balloon expandable endoprosthesis were utilized in the celiac artery.On (b)(6) 2020 celiac artery stenosis was reported.
Event or Problem Description
On (b)(6) 2020 a patient underwent aortic aneurysm treatment within the tambe 1701 clinical study.Two gore® viabahn® vbx balloon expandable endoprosthesis were utilized in the celiac artery.On (b)(6) 2020 celiac artery stenosis was reported.On february 17, 2021 documentation was received indicating the patient had an imaging test of unknown modality showing occlusion of the celiac trunk.However the gray-scale, pulse wave doppler and color flow duplex imaging performed on this day showed that the celiac artery was patent with normal flow velocities and doppler profile.Of note this exam could be in error, as this vessel was technically difficult to examine.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.

• 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
• MDR Report Key: 11354623
• Report Number: 2017233-2021-01688
• Device Sequence Number: 3980137
• Product Code: PRL
• UDI-Device Identifier: 00733132637270
• UDI-Public: 00733132637270
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 03/11/2023
• Device Model Number: BXA073902A
• Device Catalogue Number: BXA073902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 77 YR
• Patient Weight: 66