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

Catalog Number	BXA082902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: during treatment of an occluded and severely calcified right common iliac artery in a patient who has peripheral artery disease, access was from up and over the bifurcation.The target lesion was not pre-dilated.A 7fr x 10cm terumo sheath was used to advance the 8x29 gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent) over a.035 260 glide advantage wire.As reported, it was difficult to track the vbx device to the intended treatment area.Decision was made to pull the vbx device back into the sheath.The 8x29 vbx stent was dislodged from the delivery system when the wire was being exchanged for a stiffer wire.A 7x40 sterling balloon was inserted into the dislodged vbx stent and the vbx stent was deployed in the right common iliac artery.An 8x39 vbx device was also implanted distal to the initial vbx stent with great results.The patient did not experience any adverse consequences.
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.H6 - code c20: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: the device was implanted in patient.Therefore, direct product analysis was not possible.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis warnings states: 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.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.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
H6 - code b20: engineering evaluation results: the primary reported complaint of difficulty advancing the vbx device to the target location could not be independently confirmed.There were no items received in association with this complaint to allow direct evaluation of the vbx device performance relative to the reported failure mode.A review of manufacturing records indicated the vbx device lots met all pre-release manufacturing specifications.The root cause of the reported advancement difficulty cannot be established based on the information available.After the difficulty experienced in advancing the vbx device, it was reported that the vbx device was withdrawn for a guidewire exchange back into the sheath, resulting in dislodgement of the endoprosthesis from the delivery system.The ifu provides guidance concerning removal of the vbx device and discourages retraction into the sheath following full introduction of the endoprosthesis to prevent dislodgement from the balloon catheter.The ifu instructs the user to withdraw the endoprosthesis close to the sheath to allow removal in tandem if withdrawal prior to deployment is necessary.Therefore, the root cause of the endoprosthesis dislodgment is consistent with reported use error (user tries to remove the delivery system with the stent still mounted through the sheath leading to the potential for stent migration).

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17826067
• Report Number: 2017233-2023-04301
• Device Sequence Number: 2342789
• Product Code: PRL
• UDI-Device Identifier: 00733132637553
• UDI-Public: 00733132637553
• 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
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: 12/03/2025
• Device Catalogue Number: BXA082902A
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 80 KG