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

Catalog Number BXA072902E

Device Problems Complete Blockage (1094); Device Stenosis (4066)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Requests were emailed to the study coordinator to further clarify the event.The responses were captured in the event description.A review of the manufacturing records indicated the device met pre-release manufacturing specifications.The device remains implanted in the patient.Therefore a device evaluation could not be performed.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 Description

On (b)(6) 2019, the patient was endovascular treated for a pararenal aneurysm of the abdominal aorta with a customized 4-branched stent graft component (cook medical).A gore viabahn® vbx balloon expandable endoprosthesis was used to extend the branch into the celiac trunk.Access was gained via cut down to the femoral artery.The physician reported that there was no difficulty during implantation of the device, and that the device was patent at the end of the procedure.During an unscheduled phone call of the patient with the hospital on (b)(6) 2021, the patient reported that a follow up computed angiography tomography showed that the device has occluded.Reportedly no permanent impairment of a body structure or function did occur.No preventative medical or surgical intervention was performed.Hospitalization was not required.The physician stated that the primary relationship of the occlusion is unknown.During a scheduled follow up phone call of the hospital with the patient on (b)(6) 2022, the patient confirmed that the device remains occluded, that he is doing well, and that a reintervention has neither been performed nor is a reintervention planned.The physician confirmed that the patient is totally asymptomatic and that no further interventions were required.

Manufacturer Narrative

H6: code b15: radiographic images were requested from the hospital.The images were released and shared with gore for evaluation.The imaging evaluation summary states the following: three time-points available for evaluation: pre-implantation cta dated (b)(6) 2018, post-implantation cta dated (b)(6) 2019 and post-implantation cta dated (b)(6) 2021.Comparison imaging appears to show: on (b)(6) 2019: diameter at the circumferential vbx inside the cook device appears to be 8 mm.Diameter 5 mm distal to the circumferential device location at the outer cook device wall appears to be 4.8 mm.On (b)(6) 2021, circumferential vbx device within the cook device appears to have moved or shifted toward the inner side of the cook device.Diameter at the circumferential vbx inside the cook device appears to be 7.6 mm.Diameter 5 mm distal to the circumferential device location at the outer device wall appears to be 2.1 mm.The vbx device appears to be occluded.Flow can be visualized distal to the vbx device in the celiac artery.

Manufacturer Narrative

Conclusion; a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The vbx device itself remains implanted in the patient.Therefore a product evaluation could not be performed.Radiographic images were requested from the hospital.Images of three time-points were released and shared with gore for evaluation.The imaging evaluation summary states the following: 6/20/2019 - diameter at the circumferential vbx inside the cook device appears to be ~8 mm.- diameter 5 mm distal to the circumferential device location at the outer cook device wall appears to be ~4.8 mm.10/19/2021 - circumferential vbx device within the cook device appears to have moved or shifted toward the inner side of the cook device - diameter at the circumferential vbx inside the cook device appears to be ~7.6 mm.- diameter 5 mm distal to the circumferential device location at the outer device wall appears to be ~2.1 mm.- the vbx device appears to be occluded.- flow can be visualized distal to the vbx device in the celiac artery.The reported information, including review of clinical images provided to gore, does not reasonably suggest a potential malfunction.Post-procedural images showed that circumferential vbx device within the cook device appears to have moved or shifted toward the inner side of the cook device.There appears to be no relationship with the reported vbx device occlusion.The cause of the reported vbx device occlusion could not be established with the information provided and the subsequent investigation.The instructions for use state the following: intended use/indications the gore® viabahn® vbx balloon expandable endoprosthesis is indicated for endovascular grafting of peripheral vessels.Therefore stenting the celiac trunk with a vbx device is off-label use.Furthermore, the instructions for use state the following: hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include,but are not limited to: stenosis, thrombosis or occlusion;.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14943197
• MDR Text Key: 295406529
• Report Number: 2017233-2022-03100
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2021
• Device Catalogue Number: BXA072902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2018
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 97 KG