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

Catalog Number BXA075902E

Device Problems Positioning Failure (1158); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

A1 code: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3 other code: the medical device returned to a third party for investigation.The analysis report will be shared with gore and will be evaluated appropriately.B13: additional information in regard to the event and images of the case were requested from the physician.The provided additional information is captured in the event description.H6 code b14: a review of the manufacturing records for the device verified that the lot met all prerelease specifications.H6 code b15: the information reported in the complaint, including a report from third party lab, does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.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 Description

According to the information reported to gore: on (b)(6) 2023, this patient underwent a treatment for an obstructive disease in which the physician advanced a gore® viabahn® vbx balloon expandable endoprosthesis with a.035" guidewire (terumo radifocus 260cm) from right brachial access to right subclavian artery.While trying to overcome a calcified lesion, the physician lost the guidewire from the target vessel and needed to remove the vbx without deploying it.The physician didn't remove the introducer sheath together with the endoprosthesis, in order to maintain the access.He felt a big resistance at the tip of the introducer sheath and the stent-graft disconnected from the balloon catheter and remained inside the introducer sheath, that was removed.The vascular surgeon completed the procedure with another viabahn vbx endoprosthesis using a longer introducer sheath on the same guidewire, without any complication.In order to facilitate the explant from the access site (right brachial artery), the surgeon created a small cutdown.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Emdr section h6 codes updated to reflect results of investigation.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16929083
• MDR Text Key: 315177026
• Report Number: 2017233-2023-03925
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA075902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other