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

Catalog Number BXA082902J

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: code "other" was selected as the medical device was discarded at facility.Return not possible.H6: code c19 - a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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 Description

The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of the left internal iliac artery aneurysm using a gore® viabahn® vbx balloon expandable endoprosthesis (8-29).A 7fr guiding sheath (guiding length 45cm) was inserted from the right femoral artery and advanced to the left side and the gore® viabahn® vbx balloon expandable endoprosthesis was attempted to delivery to the lesion.However, the gore® viabahn® vbx balloon expandable endoprosthesis was not able to pass through the lesion.The sheath was changed to another 7fr sheath (100cm).The gore® viabahn® vbx balloon expandable endoprosthesis (8-29) was changed to another gore® viabahn® vbx balloon expandable endoprosthesis (8-39) just in case, because the physician thought the position of the crimped stent graft on the shaft seemed moved slightly.The gore® viabahn® vbx balloon expandable endoprosthesis (8-39) was implanted without any issues.The patient tolerated the procedure.The physician considered the causes of the gore® viabahn® vbx balloon expandable endoprosthesis was not able to be passed through the target lesion are following.There was a calcification in the middle of the delivery access and the iliac artery was tortuous and the 45cm sheath was not able to reach to the target lesion (not secure entire sheath protect).

Manufacturer Narrative

Review of the file determined that this event is not reportable malfunction, as no consequences or impact to patient and no delivery system components detached.Therefore, the initial medwatch and any supplemental report submitted under manufacturer report number 2017233-2023-04371 will be retracted.

• 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18036220
• MDR Text Key: 326940125
• Report Number: 2017233-2023-04371
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: BXA082902J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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 Sex: Male