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

Device Problem Perivalvular Leak (1457)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

(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

The following was reported to gore: on (b)(6) 2020, the patient presented with an aneurysm in the left common iliac artery and underwent treatment utilizing a gore® excluder® iliac branch endoprosthesis (ibe) and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The patient tolerated the procedure.On an unknown date, during a routine follow-up, cta imaging revealed a type 1b endoleak.The physician observed the vbx device had lost it's seal due to the left iliac artery dilating, extending the endoleak to the distal internal iliac artery.On (b)(6) 2021, the patient presented with a type 1b endoleak in the left common iliac artery beginning at the previously implanted vbx device and extending into the previously treated aneurysm, and underwent reintervention utilizing an additional gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device and three gore® molding & occlusion balloon catheter's (mob).The physician utilized a unilateral approach and inserted a 18fr sheath into the left common iliac artery and advanced into the previously implanted ibe device.An 8.5fr destino sheath was then introduced through the 18fr sheath and manipulated over the flow divider of the ibe device, and an amplatz 1cm tip wire was landed deep into the posterior division.The physician then inserted an initial mob37 balloon into the 18fr sheath and positioned it proximal to the 8.5fr destino sheath.Upon initiating expansion, the physician observed a hole in the balloon and the inability to retain contrast, the physician removed the mob37 balloon and inserted a second mob37 balloon.Upon attempted expansion, the second balloon was observed to be losing contrast and was ultimately removed.The physician then also removed the 8.5fr destino sheath and inserted a third mob37 balloon over a lunderquist wire and was successfully expanded with confirmed integrity.The 8.5fr destino sheath was then reintroduced and buddied next to the third mob37 balloon and the left internal iliac artery was recannulated and an amplatz wire was again buried deep.A vbx device was introduced through and out of the 8.5fr destino sheath but ultimately failed to cross the lesion.The physician then decided to remove the 8.5fr destino sheath and introduced and advanced a 10fr gore® dryseal flex introducer sheath to the intended treatment zone and the vbx device was deployed at nominal pressure.Imaging confirmed resolution of the endoleak.The patient tolerated the procedure.

• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11375534
• MDR Text Key: 233455521
• Report Number: 2017233-2021-01705
• Device Sequence Number: 1
• Product Code: PRL
• 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
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR