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

Model Number BXA097902A

Device Problems Collapse (1099); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records indicated the device met pre-release specifications.Due to no device return, an investigation could not be performed.

Event Description

On (b)(6) 2019, a patient received treatment for a thoracoabdominal aortic aneurysm using the gore® viabahn® vbx balloon expandable endoprosthesis implanted within the superior mesenteric artery.On (b)(6) 2022, compression of the gore® viabahn® vbx balloon expandable endoprosthesis and occlusion of the superior mesenteric artery was observed by the physician.No treatment has been performed.

Manufacturer Narrative

Corrected b1: adverse event and product problem.Corrected h6: medical device problem code and investigation conclusion code.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements.The ifu states the following: ¿as with any balloon expandable stent, placement of the gore® viabahn® vbx balloon expandable endoprosthesis in vessels susceptible to severe external compression may result in permanent compression of the device.¿.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15490967
• MDR Text Key: 300647300
• Report Number: 2017233-2022-03297
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637607
• UDI-Public: 00733132637607
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: BXA097902A
• Device Catalogue Number: BXA097902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 75 YR
• Patient Sex: Female