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

Catalog Number	BXB083902A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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.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) 2024, a patient underwent a procedure for stenotic occlusion where an 8 mm x 39 mm reduced profile gore® viabahn® vbx balloon expandable endoprosthesis (gore® viabahn® vbx device) was intended to be used in the left internal iliac artery.It was reported the physician accessed the patient using a 7f unknown brand guiding sheath over an unknown brand and size guide wire to the target treatment zone.Reportedly, the target lesion was not pre-dilated, and there was no unusual resistance during advancement of the delivery catheter through the sheath.During deployment of the endoprosthesis, the balloon was inflated at nominal pressure.After maintaining pressure for 15 seconds the inflation pressure on the inflation device started to decrease.The balloon deflated and the delivery catheter was withdrawn.It was reported the endoprosthesis reached full expansion and good wall apposition was achieved.On the back table the balloon was inflated and a pinhole on the balloon was noticed.It was reported the gore® viabahn® vbx device delivery catheter did not track through any other devices (i.E., pre-existing stent implants) during the procedure.It is unknown if negative pressure was applied according to the instructions for use (ifu) during preparation.The physician does not have any suspicion as to what caused the pinhole.It was reported there was no impact to the patient.
Additional Manufacturer Narrative
Updated h6 codes: type of investigation, investigation findings, and investigation conclusion a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The primary reported complaint could not be independently confirmed because there were no items returned for evaluation.The cause for the complaint could not be established with the available information.Updated h6 codes: type of investigation, investigation findings, and investigation conclusion.
Additional Manufacturer Narrative
Add b15 - analysis of information provided by user/third party add c24 - malfunction observed without conclusive finding conclusion code remains d15 - cause not established.Engineering evaluation (video): engineering evaluation of the non-clinical videos provided from the field did not indicate a balloon rupture as the balloon cover, proximal and distal end ties were intact, making it impossible to observe the condition of the balloon.The root cause of the reported primary failure mode could not be established with the available information.Balloon leakage during inflation, was confirmed via evaluation of the non-clinical videos provided from the field.The leakage of fluid during inflation through the balloon and balloon cover demonstrated in the video is indicative of a pathway, which should not exist, between these two layers of material.

• 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: 19794962
• Report Number: 2017233-2024-05129
• Device Sequence Number: 7252522
• Product Code: PRL
• UDI-Device Identifier: 00733132658725
• UDI-Public: 00733132658725
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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 Catalogue Number: BXB083902A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/20/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2024
• 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