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

Model Number	BXA065902A
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	05/02/2023
Type of Reportable Event	Malfunction
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 device was discarded at the treating facility and was, therefore, not available for analysis.No clinical images or other items enabling direct assessment of product performance were returned for evaluation.The reported stent dislodgement during withdrawal could not be independently confirmed.However, reported event details indicate there was stent-graft displacement observed following retraction of the vbx device through a sheath.The ifu discourages withdrawal of a fully introduced stent-graft through a sheath to avoid dislocation of the endoprosthesis.Therefore, the root cause of the reported displacement of the endoprosthesis on the balloon delivery system catheter is consistent with use error as reported, specifically user tries to remove delivery system with stent still mounted leading to the potential for stent migration.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: ¿do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.".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 or Problem Description
On (b)(6) 2023, the patient underwent treatment in the common iliac artery for an unknown etiology using a 6 mm x 59 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).It was reported the physician advanced the delivery system catheter through a 7f brite tip sheath introducer and over a.035" terumo glidewire advantage guidewire (260 cm).Reportedly, the lesion was pre-dilated by percutaneous transluminal angioplasty (pta).However, during advancement resistance was met in the external iliac artery due to severe calcification, and the delivery system was unable to advance across the lesion.The delivery system was withdrawn back through the introducer sheath.Upon removal, it was observed the stent-graft has moved slightly forward on the balloon, but the stent-graft did not detach from the delivery system inside the patient.The physician suspects the stent-graft movement was due the withdrawal back through the sheath.The procedure was completed using a different vbx device.It was reported there was no impact to the patient.

• 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: 16935490
• Report Number: 2017233-2023-03930
• Device Sequence Number: 5822340
• Product Code: PRL
• UDI-Device Identifier: 00733132637218
• UDI-Public: 00733132637218
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2023

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: 06/17/2025
• Device Model Number: BXA065902A
• Device Catalogue Number: BXA065902A
• 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: 05/04/2023
• Initial Report FDA Received Date: 05/15/2023
• Date Device Manufactured: 06/19/2022
• 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