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

Catalog Number BXA065902E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Thrombosis/Thrombus (4440)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, no further investigation can be performed on the device.A product history review as well as a review of the heparin coating records and sterilization records will be performed.Please notice that this incident involves multiple devices from the same manufacturer with the following manufacturer's reference numbers: (b)(4).Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that a ct scan was asked for, as a final check, before the patient was discharged from the hospital.Following this scan, it was decided that the gore® viabahn® vbx balloon expandable endoprostheses that were used in the sma were too short and that they would like to extend these.This was not the fault of any stent, just a surgeon¿s decision.It was stated that before the intervention they received the patient¿s blood tests that were taken before the procedure.It was found that his renal function was severely impaired with a creatinine level of over 400, when the day before it was around 110.When they intervened surgically to investigate, they found that both stents in both renal arteries were fully occluded and the thrombus formations could not be removed.The thrombus formation extended into the parts of both renal arteries that were not covered in stents and into the kidneys as well.Reportedly, it was deemed that both kidneys were no longer functioning and the best thing for the patient was to prepare him for dialysis.In a former procedure 1 week ago 4 gore® viabahn® vbx balloon expandable endoprostheses were used to line the renal arteries.

Manufacturer Narrative

Evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Images were requested but not provided yet.If they were made available, then an imaging evaluation will be performed.Please notice that this incident involves multiple devices from the same manufacturer with the following manufacturer report numbers: 2017233-2021-02521, 2017233-2021-02522, 2017233-2021-02523.

Manufacturer Narrative

As the device remains implanted, no further investigation of the device can be performed.As no images were provided, no imaging evaluation can be conducted.The physician was asked if there is a reason or root cause for the stenosis, but he stated that there isn't an obvious reason that this took place.Furthermore it was stated that there is no known root cause in patient history for the occlusion of the renal stents.With the information provided to gore, the cause of the reported event cannot be established.In the instruction for use for the gore® viabahn® vbx balloon expandable endoprosthesis the following is stated: hazards and adverse events procedure related: 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: vessel thrombosis, occlusion device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.

Event Description

It was reported to gore that the patient underwent a third endovascular treatment for the aorta.It was stated that the patient had previous endovascular procedures on unknown dates.The first procedure was related to a rupture at the aortic bifurcation and a second one for an acute rupture of the thoracic aorta.On (b)(6) 2021, the third procedure was a branched endovascular aortic aneurysm repair (bevar) with several gore® viabahn® vbx balloon expandable endoprostheses to connect the previous implanted stents.It was reported to gore that after a follow-up ct scan was performed, it was noticed that the implanted gore® viabahn® vbx balloon expandable endoprostheses in the sma were placed too short and that they need to be extended.It was stated that on (b)(6) 2021, performed blood tests revealed that the patient¿s renal function was severely impaired (creatinine level > 400 vs 110 the day before).During a surgical intervention on the same day, it was realized that all four gore® viabahn® vbx balloon expandable endoprostheses that were implanted in the renal arteries were fully occluded.The thrombus formations extended into the not stented parts of both renal arteries and kidneys and the thrombus could not be removed.In consequence both kidneys appeared to be no longer functioning and that the patient needed to be prepared for dialysis.Additionally, the sma was extended as originally intended with no reported issues.The physician stated that the patient is responding well to the dialysis.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12777407
• MDR Text Key: 280543021
• Report Number: 2017233-2021-02524
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Catalogue Number: BXA065902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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 Outcome(s): Disability
• Patient Age: 69 YR
• Patient Sex: Male