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

Catalog Number BXA065902E

Device Problems Complete Blockage (1094); Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problem Aneurysm (1708)

Event Date 08/01/2022

Event Type  Injury  

Event Description

The patient originally came in for an emergency bevar procedure on (b)(6) 2022.As part of this procedure, they used a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device (b)(4)) to preserve his right renal artery ¿ he has no left kidney due to a previous procedure.As part of the follow up, a scan was performed in (b)(6) 2022 and it was found that there was a type 1 c endoleak coming from the right renal artery and filling the aneurysm sac, as this stent had not been placed far enough into the renal artery.A reintervention is required to reline the renal artery.

Manufacturer Narrative

No specific patient details have been provided.Therefore the patient initials reflect the w.L.Gore reference number.A requests was emailed to the physician to provide further information to the event.The provided information is captured in the event description.Images of the case and post-procedural images have been requested from the physician for evaluation.Data pending.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

Added health effect - clinical code.Code h6-b13: a requests was emailed to the physician to provide further information to the event.The provided information is captured in the event description.Code h6-b15: images of the case and post-procedural images have been provided and are being evaluated.

Event Description

On (b)(6) 2022, the patient underwent an emergency branched endovascular aortic repair (bevar) procedure for an abdominal aortic aneurysm with a customized aortic endograft (cook medical).As part of this procedure, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device, sn (b)(6)) was used as a branch device to the right renal artery.Reportedly the vbx device was appropriately sized in the case, and positioned appropriately over the lesion to ensure sufficient distal landing zone.It was reported that no difficulties during advancement and deployment of the vbx device were experienced.As part of the follow up, a scan was performed in (b)(6) 2022 and it was found that there was a type 1c endoleak coming from the right renal artery and filling the aneurysm sac.On the images the vbx device appeared to be undersized, as if this stent had not been placed far enough into the renal artery.Reportedly the physician suspects sac progression.On (b)(6) 2022, a reintervention was performed to re-line the right renal artery with a longer vbx device.During this procedure premature separation of the endoprosthesis from the delivery catheter occurred (captured with (b)(4)).During removal of the endoprosthesis guidewire access to the right renal artery was lost.Access could not be re-cannulated because but there was now too much damage to the previously implanted vbx device, sn (b)(6), so the procedure was abandoned.On (b)(6) 2022, a further reintervention was performed to resolve the endoleak.Reportedly they could not cannulate the right renal artery due to damage sustained to the implanted vbx device in last the intervention.After several attempts the damage to the vbx device was severe that the renal artery fully occluded which also resolved the endoleak.It was believed that the right kidney is somehow gaining blood from two lumbar arteries which are close by, however the patient is now scheduled for a kidney transplant, because the patient has no left kidney due to a previous procedure.

Manufacturer Narrative

H6-codes b15 and c19 images of the case and post-procedural images were provided from the hospital for evaluation, and have been evaluated by a clinical imaging specialist.The imaging evaluation summary stated the following: no pre-implantation imaging available for evaluation, thereby, not allowing size measurements for the right renal artery (rra) to be confirmed and disease progression cannot be confirmed.On the (b)(6) 2022 cta, axial imaging shows contrast outside the implanted devices.The aortic device is not a gore device, however, the vbx in the rra is a gore device.Possible lack of device apposition in the rra.Contrast in the sac appears to originate from the rra, thereby confirming a type 1c endoleak and is consistent with the event description summary.3d centerline images show at least 4.7 cm of distal device seal in the rci and at least 1.9 cm of seal of the distal device in the lci.Imaging shows ~5 mm of stent in the rra.Intra-operative angiogram images dated (b)(6) 2022 shows the rra to be patent on the 2:27pm angio run.Multiple attempts to cannulate the rra appear to take place.Images at 2:57pm show successful cannulation of the rra.The rra does not appear to be patent on the 6:04pm angio run.The sheath is advancing from access retrograde up to and including the 3:04pm angio runs.The sheath is advancing from access above the rra on the angiogram runs at 5:50pm.The stent pattern on the 5:52pm run shows one device implanted in the rra.The rra does not appear to be patent on the 6:04pm imaging.Premature separation of the endoprosthesis from the delivery catheter cannot be confirm with available imaging.The post-implantation cta dated (b)(6) 2022 shows flow in the rra.The endoleak 1c is not resolved on this last time-point submitted for evaluation.Lack of stent apposition in the rra is identified.Images show ~4.5 mm of stent in the rra.

Manufacturer Narrative

Cause investigation and conclusion a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The device remains implanted in the patient.Therefore a device evaluation could not be performed.Images of the case and post-procedural images were provided by the hospital and an imaging evaluation wa performed.The imaging evaluation summary states the following: no pre-implantation imaging available for evaluation, thereby, not allowing size measurements for the right renal artery (rra) to be confirmed and disease progression cannot be confirmed.On the (b)(6) 2022 cta, axial imaging shows contrast outside the implanted devices.The aortic device is not a gore device, however, the vbx in the rra is a gore device.Possible lack of device apposition in the rra.Contrast in the sac appears to originate from the rra, thereby confirming a type 1c endoleak and is consistent with the event description.3d centerline images show at least 4.7 cm of distal device seal in the rci and at least 1.9 cm of seal of the distal device in the lci.Imaging shows ~5 mm of stent in the rra.Intra-operative angiogram images dated (b)(6) 2022 shows the rra to be patent on the 2:27pm angio run.Multiple attempts to cannulate the rra appear to take place.Images at 2:57pm show successful cannulation of the rra.The rra does not appear to be patent on the 6:04pm angio run.The sheath is advancing from access retrograde up to and including the 3:04pm angio runs.The sheath is advancing from access above the rra on the angiogram runs at 5:50pm.The stent pattern on the 5:52pm run shows one device implanted in the rra.The rra does not appear to be patent on the 6:04pm imaging.The post-implantation cta dated (b)(6) 2022 shows flow in the rra.The endoleak 1c is not resolved on this last time-point submitted for evaluation.Lack of stent apposition in the rra is identified.Images show ~4.5 mm of stent in the rra.The event description, including returned clinical images, does not reasonably suggest a potential malfunction has occurred.The reported endoleak and device occlusion represent known complications or adverse events 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 and treatment regimen, patient-related risk factors and disease progression.No allegation of device malfunction, such as stent collapse or structural deformation was indicated with respect to device performance.The instructions for use the following is stated: adverse events potential clinical and device adverse events possible adverse events and complications that may occur with the use of this device or in any endovascular procedure and require intervention include, but are not limited to: occlusion, stenosis, endoleak; in the present case the vbx device was used in a complex aortic repair procedure.The instructions for use the following is stated: intended use/indications the gore® viabahn® vbx balloon expandable endoprosthesis is indicated for the treatment of: de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation; de novo or restenotic lesions in the visceral arteries; isolated visceral, iliac, and subclavian artery aneurysms; or traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries).

• 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: 15470433
• MDR Text Key: 300441975
• Report Number: 2017233-2022-03339
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Catalogue Number: BXA065902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Male