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

Model Number BXAL085901A

Device Problem Compatibility Problem (2960)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Additional devices included on this report are as follows: catalog #ceb231010a/ serial (b)(4) which is captured in manufacturer report #3013164176-2021-01256.Concomitant medical products and therapy dates: clopidogrel 75mg tablet, aspirin 325mg tablet, acetaminophen 500mg tablet, metoprolol tartrate 25 mg tablet, lisinopril 10mg tablet, ipratropium-albuterol, omeprazole 20mg capsule.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), device related complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to, thrombosis or occlusion.According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoprosthesis occlusion, and occlusion of device or native vessel.Furthermore, the indications for use states that the gore® excluder® iliac branch endoprosthesis (ibe) is intended to be used with the gore® excluder® aaa endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy including, but not limited to, a minimum common iliac diameter of 17 mm at the proximal implantation zone of the ibe.

Event Description

On (b)(6) 2021 the patient underwent endovascular treatment of an abdominal aortic aneurysm and left iliac artery aneurysm using gore® excluder® iliac branch endoprostheses and gore® viabahn® vbx balloon expandable endoprostheses (vbx).A gore® excluder® iliac branch component was placed in the patient's left common iliac artery, and a vbx device was placed in the patient's left internal iliac artery.It was noted that the case was off of ifu due to the patient's proximal common iliac artery origin being small.On (b)(6) 2021 the patient presented for post-op follow-up.The patient reported having left leg coldness, numbness, and thigh and hip claudication while standing or walking since (b)(6) 2021.The patient had been unable to palpate a pulse in the left foot.Normal motor and sensory function of the patient's left foot was reported by the physician, and the physician confirmed that no left femoral, popliteal, or pedal pulses were able to be palpated.A duplex scan was performed and a clot was observed in the patient's common iliac artery.The cause of the clot was reportedly due to the small size of the patient's common iliac artery origin.The iliac branch component was occluded.Furthermore, thrombus was noted within the vbx device in the patient's left internal iliac artery.It was reported that the patient did not have limb threatening ischemia.A thrombectomy and angiogram were planned for a later date.On (b)(6) 2021 the reintervention was performed.A bridging component was used to reline the ibe device and cover the patient's internal iliac artery, excluding the vbx device.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

H.6.Investigation findings: code 213 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), device related complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to, thrombosis or occlusion.According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoprosthesis occlusion, and occlusion of device or native vessel.Furthermore, the indications for use states that the gore® excluder® iliac branch endoprosthesis (ibe) is intended to be used with the gore® excluder® aaa endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy including, but not limited to, a minimum common iliac diameter of 17 mm at the proximal implantation zone of the ibe.H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 50.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12666161
• MDR Text Key: 283813924
• Report Number: 2017233-2021-02479
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637836
• UDI-Public: 00733132637836
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BXAL085901A
• Device Catalogue Number: BXAL085901A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 75 KG