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

Model Number	BXA075902A
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
Event or Problem Description
The following information was reported to gore from medrio clinical study (b)(6): on (b)(6) 2020, the patient was treated for a thoracoabdominal aortic aneurysm using three gore® viabahn® vbx balloon expandable endoprostheses, implanted in the right renal artery ((b)(4)/bxa067902a), left renal artery ((b)(4)/bxa067902a) and superior mesenteric artery ((b)(4)/bxa075902a).On (b)(6) 2020, thrombosis was observed within the gore® viabahn® vbx balloon expandable endoprosthesis ((b)(4)/bxa067902a) located in the right renal artery.On (b)(6) 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 ((b)(4)/bxa067902a).On (b)(6) 2021, stenosis was observed within the gore® viabahn® vbx balloon expandable endoprosthesis ((b)(4)/bxa075902a) located in the distal superior mesenteric artery stent.It was also noted there was stenosis within the gore® viabahn® vbx balloon expandable endoprosthesis ((b)(4)/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 ((b)(4)/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 ((b)(4)/bxa067902a) of the distal left renal artery with a 6 x 20 mm angioplasty balloon.
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.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 15058683
• Report Number: 2017233-2022-03138
• Device Sequence Number: 4668090
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• 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: 02/22/2023
• Device Model Number: BXA075902A
• Device Catalogue Number: BXA075902A
• 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: 02/24/2020
• 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