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

Model Number	BXA093901A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the patient underwent treatment in the left common iliac artery for aortoiliac occlusive disease using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).It was reported while the physician was advancing the vbx device using an 8f sheath, resistance was met due to extensive calcification throughout the left iliac artery system.Reportedly, the vbx device reached the target treatment zone.However, while adjusting the stent graft, it became dislodged from the balloon catheter.A second balloon catheter was advanced to assist with device expansion.The vbx device was successfully implanted.The physician suspects the stent graft dislodged from the balloon catheter due to the resistance during advancement from the extensive calcification in the iliac system.No impact to the patient was reported.
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 manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Engineering evaluation: the reported dislodgement of the endoprosthesis during advancement positioning of the vbx device, could not be independently confirmed.No items were returned to gore for evaluation.The cause for the reported endoprosthesis dislodgement is considered to be related to the patient condition, extensive vessel calcification, as reported.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail, and there are applicable statements.The ifu states the following: f.Introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis 5.Using fluoroscopic guidance, advance the delivery catheter over the guidewire via the angiographic sheath.Advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery catheter and sheath together as a unit 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16467976
• Report Number: 2017233-2023-03770
• Device Sequence Number: 12657195
• Product Code: PRL
• UDI-Device Identifier: 00733132637348
• UDI-Public: 00733132637348
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2025
• Device Model Number: BXA093901A
• Device Catalogue Number: BXA093901A
• 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: 02/15/2023
• Initial Report FDA Received Date: 03/02/2023
• Date Device Manufactured: 06/09/2022
• 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
• Patient Sex: Unknown