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

Device Problem Device Dislodged or Dislocated (2923)

Event Date 02/13/2024

Event Type  Injury  

Event Description

On (b)(6) 2020, patient underwent an endovascular procedure to treat an abdominal aortic aneurysm where an unknown size gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent graft) was implanted in the internal iliac artery.On (b)(6) 2024, fsa called and notified physician reported patient has a possible unspecified leak with a possible reintervention.Further information to be provided.On 2/14/2024, it was reported there was a type ii endoleak, suspected type 1 endoleak, and possible type 3 component disconnection.Plans for reintervention surgery will be scheduled for (b)(6) 2024.On 3/5/2024, it was reported patient underwent reintervention surgery on (b)(6) 2024 to treat the endoleak(s).It was reported an aortic extender was placed proximally, but the there was a leak in the ibe gate.Reportedly, during the procedure angiography was performed and a brisk type iii junctional leak was noted at the vbx stent graft.It appeared the vbx stent graft had recoiled (reduced in diameter) over time.Physician ballooned it with a 12 or 14 balloon, and the leak was resolved.The cause of this reduction in diameter is unknown.The cause of the endoleak remains unknown.It was reported the patient tolerated the procedure.

Manufacturer Narrative

Type of investigation - code b22 - a review of the manufacturing records for the device could not be conducted because the serial / lot number remains unknown.Without a lot number or device serial number, the manufacturing date and / or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.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.

Manufacturer Narrative

Update investigation conclusion code: d15 - cause not established.D12 - known inherit risk of device.Update type of investigation: b15 - analysis of information provided by user/third party.The reported endoleak represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up, patient-related risk factors and disease progression.No holes, tears or other damage concerning the structural integrity of the device graft material was indicated.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use hazards and events section states: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: malapposition.Patient images were provided.Imaging analysis was performed, and the following was reported: one time-point is available for evaluation: post-implantation cta dated (b)(6) 2023.Contrast is seen in the rci.There is an ibe device implanted in the rci.Contrast is pooling near the ibe gate and the stent extending into the right internal iliac artery.There is questionable stent wall apposition in the riia at the level of this gate and stent overlap.Contrast poolings are not increased on the delayed series imaging thereby suggesting a type iii endoleak.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18881785
• MDR Text Key: 337411448
• Report Number: 2017233-2024-04697
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 85 YR