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

Catalog Number BXA073902E

Device Problems Difficult to Insert (1316); Difficult to Advance (2920); Premature Separation (4045)

Patient Problem Renal Impairment (4499)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2022, a patient presented for aortic treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.It was reported that the physician attempted to advance the vbx device without protection (the sheath selected was too short) to the aortic lesion, but it failed to cross.The vbx device was then removed from the patient.The lesion was ballooned, and the vbx device was again advanced without sheath protection, but still could not cross the treatment site.When the physician attempted to remove the vbx device by pulling it back through the sheath, the stent dislodged from the balloon.The physician was able to push the dislodged vbx device to the intended treatment site using the balloon catheter and then successfully deploy the vbx device over the lesion.There was no reported harm to the patient.

Manufacturer Narrative

The manufacturing records are being reviewed.The device is being returned to gore for evaluation.Additional information to the event, potential aneurysm growth and dicom imaging series have been requested.The answer is 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.(b)(4) (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

H6: b15 and c19: dicom images have been provided for evaluation.The imaging evaluation performed by a clinical imaging specialist showed 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 (page 10).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 the 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

H6-code b13: the device is still being returned to gore for evaluation.Additional information to the event has been provided which is captured in updated description in section b5.H6-code b15: dicom imaging series 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 (captured with (b)(4)).On (b)(6) 2022, a reintervention was performed to re-line the right renal artery with a longer vbx device (sn (b)(6)) to resolve the endoleak.Access was gained through the groin and the vbx device was advanced over a stiff 0.035¿ rosen guidewire and through a 7fr tourguide¿ steerable sheath (medtronik).It was planned to deploy the vbx device through the sheath straight into the branch.Reportedly the angle to deploy the vbx device was quite acute, and the physician was attempting to push the vbx device over a tight u-bend.When the vbx device was further advanced through the previously implanted vbx device the physician tried to pull the vbx device back into the steerable sheath to reposition it, at which point the endoprosthesis came off the balloon and was loose in the aorta.It was reported that the physician suspects that the vbx device was caught on something as it entered the branch of the customized aortic endograft (cook medical).After 2 hours of trying, the physician managed to snare the endoprosthesis and removed it through the sheath.Reportedly there were no observations of damage to the vbx device or accessory devices, neither before use, nor as a result of the difficulty experienced.An attempt to reline the right renal artery was then made through a brachial access, but there was now too much damage to the previously implanted vbx device (sn (b)(6)) to re-gain access with a guidewire to the renal artery, 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

Cause investigation and conclusion.A review of the manufacturing records indicated the device met pre-release specifications.The device has been shipped to gore for evaluation but for unknown reason the package was rejected at the us custom and returned to the sender.Since then gore scheduled several collections of the device at the hospital to return it to gore.All collections failed.Eventually the hospital could not longer locate the device.Neither the primary (resistance during insertion) nor the secondary (endoprosthesis dislodged from device) reported device failure mode could be independently confirmed.No physical items were returned to enable direct evaluation of product performance relative to the reported complaint.The provided photographs do not provide product performance information.Evaluation of the provided clinical images confirm the reported type 1c endoleak which the physician attempted to resolve using the vbx device in this incident (s/n (b)(6)).The imaging evaluation could not confirm difficulty during insertion and advancement nor separation of the endoprosthesis from the delivery system.The cause for the reported resistance during insertion is considered to be related to patient anatomy as reported in the complaint.The physician suspected the endoprosthesis interacted with something during advancement through the existing aortic endograft which led to its dislodgement.Dislodgement of the endoprosthesis as reported in the complaint is consistent with reasonably foreseeable misuse as defined in the device instructions for use (ifu) and the use fmea.Reasonably foreseeable misuse could not be confirmed, but withdrawal of the device into the introducer sheath with the endoprosthesis still mounted reportedly occurred during the procedure for the purpose of repositioning.The cause for the endoprosthesis dislodgement could not be established.The vbx device instructions for use (ifu) was reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified as related to the primary device failure mode in the complaint.Introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis: note: if excessive resistance is felt as the gore® viabahn® vbx balloon expandable endoprosthesis is introduced through the hemostasis valve, remove and inspect the delivery catheter for damage.Note: should it become necessary to remove either a partially expanded or non-deployed gore® viabahn® vbx balloon expandable endoprosthesis from the vessel, do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath after the endoprosthesis is fully introduced.To remove the gore® viabahn® vbx balloon expandable endoprosthesis, it can be withdrawn to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, neither the gore® viabahn® vbx balloon expandable endoprosthesis nor the introducer sheath should be reused.Do not attempt to pull an endoprosthesis system that has been either partially expanded or not expanded back into the introducer sheath, as dislodgement of the endoprosthesis from the balloon may occur.

• 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: 15439995
• MDR Text Key: 300698120
• Report Number: 2017233-2022-03324
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2024
• Device Catalogue Number: BXA073902E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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