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

Model Number	BXA115901A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on june 14, 2023, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was intended for use in the left common iliac artery during treatment of a severely calcified lesion.The physician gained access from the left superficial femoral artery and advanced an 0.035" rosen guide wire across the calcified lesion.However, the physician was unable to advance a terumo destination guiding sheath (size unknown) through the calcification.After multiple attempts were made to advance the vbx device across the calcified lesion, the vbx device had become dislodged from the delivery catheter.The physician made the decision to remove the vbx delivery catheter, advance a 4mm balloon (manufacturer unknown) and inflate the device where it was.The physician advanced an 8mm balloon (unknown manufacturer) to successfully complete the procedure.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.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.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
Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The device remains in the patient.Consequently, a direct product analysis was not possible.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.The following ifu statements were identified as related to the primary device failure mode in this complaint.F.Introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis 1.Select the compatible size introducer sheath from table 1.Always use an appropriately sized sheath for the implant procedure.It is advisable to use a sheath or guide catheter that is long enough to cross the lesion.Use of a guide sheath or guide catheter minimizes the risk of dislodging the endoprosthesis from the balloon during tracking.Use standard interventional techniques to introduce the gore® viabahn® vbx balloon expandable endoprosthesis to the target lesion.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17136773
• Report Number: 2017233-2023-04021
• Device Sequence Number: 3941326
• Product Code: PRL
• UDI-Device Identifier: 00733132637737
• UDI-Public: 00733132637737
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 04/30/2025
• Device Model Number: BXA115901A
• Device Catalogue Number: BXA115901A
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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: 82 YR
• Patient Sex: Female