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

Catalog Number BXA115902E

Device Problem Complete Blockage (1094)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 06/13/2022

Event Type  Injury  

Event Description

On the (b)(6) 2022, gore received a report about an event that occurred on the (b)(6) 2022 at the (b)(6) university hospital involving two gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn device) and five gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).The patient presented with blood vessel occlusion starting from the iliac arteries up to the aortic bifurcation.It was reported that the vascular surgeon that achieved the vascular access through the common femoral artery indicated that the arteries were in very poor condition.Patient is wheel chair based and presented with rest pain, very bad blood circulation downstream, arteries presenting calcific occlusions, arterial walls in bad condition with predisposition to rupture.Patient had very bad life style all his life and it was reported that he had series of strokes in the last 10 years.The physician proposed the use of two gore® viabahn® endoprosthesis with propaten bioactive surface in each of the common iliac arteries because the stenosis extended from the common iliac arteries up to the aortic bifurcation and two gore® viabahn® vbx balloon expandable endoprosthesis in a kissing stent formation up to the aortic bifurcation.It was reported that vascular access to the aorta was difficult to achieve due to calcification of the common iliac artery.No complications were reported during while gaining access through the arm.It was reported that the viabahn and the vbx devices were uneventfully deployed.Following the successful deployment of the devices, a pigtail catheter contrast enhanced imaging was performed and it was discovered that an occlusion occurred on the viabahn and vbx devices implanted on the right hand side.A blood clot was believed to be the cause of the occlusion and a balloon embolectomy was conducted.After the embolectomy, another contrast enhanced imagining was performed and it revealed patency on the viabahn and the vbx on the right hand side and simultaneously revealed occlusion on the devices implanted on the left hand side.It was reported that the physician believed the aorta to be damaged above the level of the kissing stents thereby initiating the sequential occlusion of the devices.Therefore, it was decided to further extend the kissing stent formation with one vbx device on each side along the aorta.After the successful implantation of these vbx devices, patency was confirmed in the devices on the left hand side but the devices on right hand side were revealed to be occluded.It was reported that an extra vbx device was implanted to maintain patency along the devices located on the left hand side and was post-dilated to 16 mm.The initial plan was a femoro-femoral bypass to regain patency along the right hand side.However, after performing a pigtail catheter contrast enhanced imaging following this deployment of the final vbx, both sides were revealed to be occluded, therefore an axillo-bifemoral bypass was performed.It was confirmed that a total of 7 devices were implanted and all of them were occluded by the end of the event.Dissection of the aorta was confirmed to be the leading root cause for the reported occlusions.It was reported that during the event the viabahn and vbx devices were deployed as specified through an 8 fr sheath and all endoprostheses were revealed to be patent and functional at some point during the procedure.Its confirmed that the vbx/vsx deployed perfectly and they performed as they were supposed to do.The physicians believed that the occlusions resulted from the damages to the aorta caused by the difficulty encountered while trying to gain vascular access before the endoprostheses were deployed also partially due to the patient's pre-existing frail tissues.It is confirmed that physician stated that the occlusions have nothing to do with devices used as they remained implanted.The root cause is solely based on the patient condition.

Manufacturer Narrative

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

H6: corrected imdrf codes.

• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14998184
• MDR Text Key: 295771022
• Report Number: 2017233-2022-03116
• 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
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA115902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male