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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following publication was reviewed: "outcomes of the gore excluder iliac branch endoprosthesis using division branches of the internal iliac artery as distal landing zones¿ mario d¿oria, md, et al.Journal of endovascular therapy published april 1 2020.Purpose: to evaluate the outcomes of the gore excluder iliac branch endoprosthesis (ibe) using division branches of the internal iliac artery (iia) as distal landing zones.Materials and methods: between january 1, 2014, and december 31, 2018, 74 patients (mean age 74 ± 7 years; 72 men) treated for aortoiliac or common iliac artery aneurysms had an ibe deployed with distal landing of the side branch within the main trunk (n=60) of the internal iliac artery (iia) vs within a division branch (n=25).Thirteen (17%) patients received bilateral ibe implantations for a total of 85 vessels evaluated.The article notes in table 4 an allegation of branch disconnection and reintervention on a gore® viabahn® vbx balloon expandable endoprosthesis.

Manufacturer Narrative

Additional 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.

• 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
• MDR Report Key: 10399803
• MDR Text Key: 205167386
• Report Number: 2017233-2020-01125
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 12/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention