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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

The purpose of the study was to evaluate the performance of 60 cases (male 50, female 10, mean age 72) at a single facility in which gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted in the external iliac artery.Hypertension, coronary artery disease, diabetes, dialysis, emphysema, dyslipidemia, and smoking were reported as comorbidities.Vbx device was implanted in the aorta-external iliac artery, common iliac-external iliac artery, or external iliac artery.Endoaterectomy was performed in 31 cases and patch plasty was performed in 28 cases.The primary patency rate was 94% at 1 year and 91% at 2 years, and the secondary patency rate was 94% at both 1 and 2 years.Besides occlusion/stenosis (number of cases unknown), edge dissection (3 cases), embolism (3 cases), infection (1 case), and bleeding during endarterectomy (2 cases) were reported as complications.Infection case: an endarterectomy using bovine pericardium and a vbx device implantation were performed for the right external iliac artery lesion.Postoperatively, the bovine pericardium in the inguinal region became infected, which spread to the vbx device, and the vbx device was removed by laparotomy 6 weeks after implantation.One of the occlusion cases: two vbx devices were implanted for a right external iliac artery lesion.Eight months after implantation, occlusion of the vbx devices was observed.The occlusion appeared to be due to the progression of the proximal residual disease.Due to the patient's continued smoking, the occluded vbx devices were not repaired immediately after the occlusion.However, six weeks later, due to worsening symptoms, a thrombectomy was performed and an additional vbx device was implanted at the residual lesion.No relining of the initially implanted vbx devices was performed.Three weeks after the reintervention, the initially implanted vbx devices were occluded again.The patient underwent laparotomy for repair.The patient's hit antibodies were negative.Patient and event information were requested, but author declined to provide any details.As a result, further investigation was not possible.Cause of the reported event cannot be established based on the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.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

The following information was obtained from a conference presentation/study: the purpose of the study was to evaluate the performance of 60 cases (male 50, female 10, mean age 72) at a single facility in which gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted in the external iliac artery.Hypertension, coronary artery disease, diabetes, dialysis, emphysema, dyslipidemia, and smoking were reported as comorbidities.Vbx device was implanted in the aorta-external iliac artery, common iliac-external iliac artery, or external iliac artery.Endoaterectomy was performed in 31 cases and patch plasty was performed in 28 cases.The primary patency rate was 94% at 1 year and 91% at 2 years, and the secondary patency rate was 94% at both 1 and 2 years.Besides occlusion/stenosis (number of cases unknown), edge dissection (3 cases), embolism (3 cases), infection (1 case), and bleeding during endarterectomy (2 cases) were reported as complications.Infection case: an endarterectomy using bovine pericardium and a vbx device implantation were performed for the right external iliac artery lesion.Postoperatively, the bovine pericardium in the inguinal region became infected, which spread to the vbx device, and the vbx device was removed by laparotomy 6 weeks after implantation.One of the occlusion cases: two vbx devices were implanted for a right external iliac artery lesion.Eight months after implantation, occlusion of the vbx devices was observed.The occlusion appeared to be due to the progression of the proximal residual disease.Due to the patient's continued smoking, the occluded vbx devices were not repaired immediately after the occlusion.However, six weeks later, due to worsening symptoms, a thrombectomy was performed and an additional vbx device was implanted at the residual lesion.No relining of the initially implanted vbx devices was performed.Three weeks after the reintervention, the initially implanted vbx devices were occluded again.The patient underwent laparotomy for repair.The patient's hit antibodies were negative.The following two case reports were also presented.Case 1.Captured in mpdcase-00010421.77-year-old, male.The patient underwent an endovascular treatment to repair chronic limbthreatening ischemia (clti) in the right external iliac artery using two vbx devices (7x79).The guidewire was passed through the false lumen because it was not possible to pass through the true lumen, and the vbx devices were also implanted in the false lumen.A partial lesion remained proximally located from the implantation site, but it was left as it was and the patient was monitored.Six months after the procedure, the vbx devices were patent, but the remained lesion at the proximal site had progressed, so a bare metal stent was implanted, and a vein patch plasty was performed in the common femoral artery because distal run-off remodeling was observed.However, blood flow in the superficial femoral artery was reduced and the vbx device was occluded the next day.It was considered that the stenosis/occlusion was caused by the blockage during patch plasty.For repair, the common femoral artery was reconstructed and an fpak bypass was created.The patient tolerated the procedure, and is making steady progress.Case 2.Captured in mpdcase-00010422.65 years old, female.The patient underwent an endovascular treatment to repair a stenosed external iliac artery due to urologic cancer invasion using a vbx device.Pre-dilation with a high-pressure balloon was performed but the lesion was not sufficiently dilated.The vbx device was implanted in the lesion under the condition, which resulted that the vbx device was not fully expanded partially and some narrowing of the lumen remained.After the procedure, a bare metal stent was added to expand the vbx device, but it didn¿t succeed and contributed to the stenosis.The vbx device was occluded one month after implantation.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15569404
• MDR Text Key: 301524675
• Report Number: 2017233-2022-03351
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR