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

Catalog Number BXAL087901J

Device Problems Break (1069); Activation Failure (3270)

Patient Problem Aneurysm (1708)

Event Date 12/23/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient underwent endovascular treatment of a thoracic aortic aneurysm using gore® dryseal flex introducer sheath (dsf) and gore® tag® conformable thoracic stent graft with active control system (ctagac).During the treatment, a 22 fr dsf was used from a right leg but was not able to advance at a narrow part of a right external iliac artery.The physician decided to make an endo-conduit in the right access.Gore® viabahn® vbx balloon expandable endoprosthesis, bxal087901j, was implanted after plug embolization of a right internal iliac artery.The vbx was ballooned using power flex f10 x 2 cm.Attempt was made to advance the 22 fr dsf, however the dsf was not able to advance into the vbx because the vbx was not fully deployed due to a narrow diameter of the right external iliac artery.The distal edge of the sheath might be damaged then the physician decided to use new 22 fr dsf.The vbx.Was ballooned using gekira f12.During several ballooning, a vessel was ruptured at the distal side of the vbx.To treat the rupture, additional gore® viabahn® vbx balloon expandable endoprosthesis, bxal085901j, was overlapped implanted distally.A blood pressure became stable.During ballooning using gekira f14, vbx fracture was observed.A proximal side of the right common iliac artery may be ruptured.Additionally, a contralateral leg was implanted, however both distal rupture and proximal rupture were not resolved.The physician decided to block an aorta using coda balloon and perform the tevar then additional evar.The tevar using gore® tag® conformable thoracic stent graft with active control system (ctagac) devices was performed.The evar using gore® excluder® aaa endoprostheses and gore® viabahn® endoprosthesis with heparin bioactive surface was performed.An angiography revealed no leak.The procedure was finished.The patient tolerated the procedure.The physician stated that it was unknown whether the distal rupture was due to the ballooning or because the blood vessel were too narrow.Reportedly, two serial numbers were reported for dsf devices, but it was unknown which was the first or second dsf.It was unknown whether the vbx fracture occurred on any of the device or both devices.The proximal rupture was suspected to have been caused by the pressure placed on the vessel by the vbx during ballooning.It was unknown about the vessel condition prior to the treatment.

Manufacturer Narrative

Code "other" was selected as the medical device remains implanted.Return not possible.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.

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.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Medical imaging evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following: focal narrowing of the graft within the right external iliac (rei) artery.Contrast visualized outside of the graft consistent with reported rupture within the rei.No further observations with respect to the reported failure modes were confirmed with the images provided for review.The images received could not be used to perform a full imaging evaluation because they did not meet dicom standard.Therefore, the extent and accuracy of the observations and findings were limited due to the completeness, format and/or quality of the images provided for review.The reported primary device failure mode concerning partial endoprosthesis expansion is consistent with observed focal narrowing of the vbx device within the right external iliac (rei) artery.The reported event details indicate the vbx device was not fully deployed due to a narrow diameter of the rei.Therefore, the root cause of the partial expansion is attributed to patient-related circumstances that may have prevented full expansion of the endoprosthesis.Updated type of investigation - b14,b15.Updated investigation findings - c19.Updated investigation conclusions - d1002, and d1001.

• 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: 16203497
• MDR Text Key: 307668579
• Report Number: 2017233-2023-03654
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXAL087901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male