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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of an iliac artery aneurysm with gore® excluder® aaa endoprostheses, a gore® excluder® iliac branch endoprosthesis and a gore® viabahn® vbx balloon expandable endoprosthesis, which was utilized in the internal iliac artery.On (b)(6) 2019 images revealed a leak in the vicinity of the internal iliac artery.On (b)(6) 2019 a reintervention took place.The vbx was observed to have pulled out of the internal iliac artery.This was reportedly due to an anatomical variance.An internal iliac artery branch was coiled.An 8mm x 79mm vbx was placed as a distal extension and the system was bridged with an 11mm x 79 mm vbx.The patient did well following the procedure.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8512503
• MDR Text Key: 141897171
• Report Number: 2017233-2019-00246
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2019
• 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
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention