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

Catalog Number BXA085901J

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/13/2022

Event Type  Injury  

Event Description

The following information was obtained from a conference presentation: on an unknown date, a (b)(6) man came to our hospital with a chief complaint of numbness and intermittent claudication of the lower limbs.He had no medical history and was current smoking.The bilateral inguinal pulses were not palpable, and contrast-enhanced ct showed obstruction from the abdominal aorta juxtarenal artery bifurcation to the bilateral external iliac arteries.On an unknown date (six months later), skin ulceration on the right lateral thigh was observed, and evt was performed using the bilateral femoral and left brachial artery approaches.The wires successfully passed through the true lumen, and four stent grafts (gore® viabahn® vbx balloon expandable endoprostheses / vbx device) and four bare nitinol stents implantation success.The first two vbx devices (8-59) were implanted from just under the renal arteries using the kissing stent technique, and the additional two vbx devices (7-79) were implanted peripherally from the previously implanted vbx devices using the kissing stent technique.The bare nitinol stents (smart® 8-100, 7-40) were implanted in bilateral external iliac arteries.After implantation, thrombus formation was observed at the right proximal end of the occlusion.Blood flow to the right lower extremity (iliac artery and femoral artery) and left renal artery was lost, and the thromboembolization was suspected, so the thrombus aspiration and balloon dilation were performed to resume blood flow.In addition, embolism was also observed in the below-the-knee artery, so thrombus aspiration and balloon dilation were performed and then blood flow in the posterior tibial artery was confirmed.During treatment, the patient showed disturbance of consciousness and paralysis of the right upper and lower limbs.Ct and mri of the head showed cerebral infarction in the right middle cerebral artery region.Since t-pa was not indicated and thrombus retrieval therapy was not available, conservative treatment was decided.Reportedly, the physician stated: regarding the cerebral infarction, the cause was considered to be the procedure for the thrombotic lesion.It is possible that sheath operation during approach or removal from the left upper arm, which was performed when a thromboembolization to the right iliac artery was suspected, or operation during wire access from the femoral artery to the aorta, may have caused the thrombus to fly into the head.During the procedure, thrombus was identified several times, which led to suspicion of hit, but postoperative tests were not positive.However, heparin was changed to argatroban during the procedure.

Manufacturer Narrative

The following information was requested via the clinical specialist, but was not available: serial number of the device.The detail of the event includes the onset date.Patient information: initials, weight, date of birth, pre-existing conditions and medications.Due to an unknown lot/serial number and no device return, an investigation could not be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13978619
• MDR Text Key: 288397975
• Report Number: 2017233-2022-02837
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA085901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2022
• Initial Date FDA Received: 04/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male