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

Model Number BXA067902A

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/15/2020

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 lot met pre-release manufacturing specifications.Due to no device return, an investigation could not be performed.

Event Description

The following information was reported to gore from medrio clinical study aaa 17-01: on august 13, 2020, the patient was treated for a thoracoabdominal aortic aneurysm using three gore® viabahn® vbx balloon expandable endoprostheses, implanted in the right renal artery (22300501/bxa067902a), left renal artery (22300500/bxa067902a) and superior mesenteric artery (22276962/bxa075902a).On september 15, 2020, thrombosis was observed within the gore® viabahn® vbx balloon expandable endoprosthesis (22300501/bxa067902a) located in the right renal artery.On september 17, 2020, a balloon angioplasty was performed to treat the stenosis within the right renal artery stent.Additionally, a medtronic everflex stent 7mm x 60mm was implanted to treat the occlusion within the gore® viabahn® vbx balloon expandable endoprosthesis (22300501/bxa067902a).On february 17, 2021, stenosis was observed within the gore® viabahn® vbx balloon expandable endoprosthesis (22276962/bxa075902a) located in the distal superior mesenteric artery stent.It was also noted there was stenosis within the gore® viabahn® vbx balloon expandable endoprosthesis (22300500/bxa067902a) located in the distal left renal artery stent.On the same day, an angioplasty procedure was performed to treat the in stent stenosis of the gore® viabahn® vbx balloon expandable endoprosthesis (22276962/bxa075902a) located in the distal superior mesenteric artery stent with a 7 x 20 mm angioplasty balloon.Additionally an angioplasty procedure was performed to treat the in stent stenosis of the gore® viabahn® vbx balloon expandable endoprosthesis (22300500/bxa067902a) of the distal left renal artery with a 6 x 20 mm angioplasty balloon.

• 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: 15055239
• MDR Text Key: 296165722
• Report Number: 2017233-2022-03139
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637492
• UDI-Public: 00733132637492
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: BXA067902A
• Device Catalogue Number: BXA067902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Date Device Manufactured: 02/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 66 KG