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

Model Number BXA073902A

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11354623
• MDR Text Key: 232847717
• Report Number: 2017233-2021-01688
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637270
• UDI-Public: 00733132637270
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: BXA073902A
• Device Catalogue Number: BXA073902A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 77 YR
• Patient Weight: 66