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

Device Problems Collapse (1099); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/26/2021

Event Type  Injury  

Event Description

The literature article: ¿physician-modified endografting for complex abdominal and thoracoabdominal aortic aneurysms¿ published by sukgu m han was reviewed.The article was published online or accepted on 26 june 2021.The use of gore® viabahn® vbx balloon expandable endoprosthesis was evaluated for endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms inner branches.In a total population of 17 patients all had a inner branch repair with gore® viabahn® vbx balloon expandable endoprosthesis.The female/men ratio was 5/12 with an average age of 76.1 years.At 30-day follow-up, overall target vessel primary patency was 98.5%, with one reintervention on postoperative day 1 for kinking of the superior mesenteric artery (sma) bridging stent across a fenestration, diagnosed on ct imaging.This was successfully treated by relining with an additional visi-pro balloon expandable stent (medtronic, minneapolis, mn, u.S.).Follow-up inner branch primary patency was 96.3% due to 1 inner branch occlusion of a lumbar artery detected at 6-month follow-up, without clinical sequelae.

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.Due to an unknown lot/serial number and no device return, an investigation could not be performed.

Manufacturer Narrative

Addition of code 1099-collapse for the superior mesenteric artery stent kink.

• 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: 14044797
• MDR Text Key: 288875639
• Report Number: 2017233-2022-02849
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male