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

Model Number	BXA067902A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15055239
• Report Number: 2017233-2022-03139
• Device Sequence Number: 17518072
• Product Code: PRL
• UDI-Device Identifier: 00733132637492
• UDI-Public: 00733132637492
• 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
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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: 02/04/2023
• Device Model Number: BXA067902A
• Device Catalogue Number: BXA067902A
• 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: 06/22/2022
• Initial Report FDA Received Date: 07/19/2022
• Date Device Manufactured: 02/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 66 KG