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

Model Number	BXA093902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent endovascular treatment of a juxtarenal abdominal aortic aneurysm in the gore® excluder® thoracoabdominal branch endoprosthesis (tambe) clinical trial.A gore® viabahn® vbx balloon expandable endoprosthesis was used during the procedure.On (b)(6) 2022, a type iii endoleak was observed in the patient's superior mesenteric artery (sma).An additional stent was placed in the treated sma segment.
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.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.
Additional Manufacturer Narrative
H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use, when overlapping (telescoping) multiple devices, the following are suggested: to ensure proper seating, at least 1 cm of overlap between devices is suggested.Endoprosthesis foreshortening should be taken into account to achieve the recommended overlap between devices.Overlapping devices should not differ by more than 1 mm in deployed diameter.H.6.Investigation findings: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.
Event or Problem Description
On (b)(6) 2022, a reintervention was performed whereby an additional gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed in the treated superior mesenteric artery segment.The additional device was used to reline the vbx device most proximal within the portal.The patient was discharged on (b)(6) 2022.
Additional Manufacturer Narrative
According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use, when overlapping (telescoping) multiple devices, the following are suggested: to ensure proper seating, at least 1 cm of overlap between devices is suggested.Endoprosthesis foreshortening should be taken into account to achieve the recommended overlap between devices.Overlapping devices should not differ by more than 1 mm in deployed diameter.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16119105
• Report Number: 2017233-2023-03624
• Device Sequence Number: 15170330
• Product Code: PRL
• UDI-Device Identifier: 00733132637355
• UDI-Public: 00733132637355
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2023

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: 11/15/2024
• Device Model Number: BXA093902A
• Device Catalogue Number: BXA093902A
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/09/2023; 02/08/2023
• Initial Report FDA Received Date: 01/08/2023
• Supplement Report FDA Received Date: 02/08/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White