MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number BXAL087901J

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problems Aneurysm (1708); Perforation of Vessels (2135); Obstruction/Occlusion (2422)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device remains implanted.Return not possible.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.

Event Description

On (b)(6) 2023, the patient underwent an endovascular treatment of an abdominal aortic aneurysm with iliac aneurysm using gore® excluder® aaa endoprostheses and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).After an iliac branch component was placed on the right side of the patient, an internal iliac component was inserted into the right internal iliac artery.The catheter insertion was difficult due to the angled vessel, and the iliac branch component was re-positioned slightly proximal and the internal iliac component was deployed.The vbx was subsequently inserted for extend into the superior gluteal artery.The catheter insertion was difficult due to the angled vessel, and the vbx was deployed near bifurcation of the superior and inferior gluteal arteries.After touching up with a non-gore balloon (gekira), a vessel perforation was confirmed near bifurcation of the superior and inferior gluteal arteries.The balloon occlusion was performed near the proximal of the iliac branch component, and the superior gluteal artery up to the internal iliac component was all embolized with coil and plug.After confirming hemostasis, the planned procedure was proceeded and the patient tolerated the procedure.

Manufacturer Narrative

Emdr section h6 e, a, b, c, d codes were updated to reflect results of investigation.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17611251
• MDR Text Key: 321826417
• Report Number: 2017233-2023-04226
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: BXAL087901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female