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

Device Problems Complete Blockage (1094); Device Stenosis (4066)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event involves two reportable complaints therefore two (2) manufacturer reports are being submitted: gore® excluder® iliac branch endoprostheses system - manufacturer report number #3013164176-2022-01314.Gore® viabahn® vbx balloon expandable endoprosthesis - present report.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

On (b)(6) 2021, the patient underwent an endovascular procedure with gore® excluder® iliac branch endoprostheses for an aneurysm which demanded distal landing in the internal iliac artery.A gore® excluder® iliac branch endoprosthesis internal iliac component (hgb device) was placed first and then extended with a gore® viabahn® vbx balloon expandable endoprosthesis.It was stated that the result looked good at perioperative angiography imaging.Reportedly, on (b)(6) 2021, 30 days after implant, the internal iliac artery is occluded.The current patient status was requested but remains unknown so far.It was requested whether a reintervention was performed but it remains unknown so far.

Manufacturer Narrative

Conclusion the serial number of the device was requested but could not be obtained.Therefore, a review of the manufacturing records could not be performed.The device remains implanted in the patient.Therefore a device evaluation could not be performed.Images dated (b)(6), 2021, were provided for investigation.The imaging evaluation showed that the devices implanted appear to be fully deployed with no evidence of kinking or device abnormality.There is no contrast visible within the vbx device indicating total occlusion.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.In the instructions for use of the device the following is stated: hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion; distal embolism; side branch occlusion;.

Event Description

On unknown date the patient underwent an endovascular procedure to embolize one of the internal iliac arteries for an aneurysm.On (b)(6), 2021, the patient underwent an endovascular procedure with gore® excluder® iliac branch endoprostheses for an aneurysm on the contralateral side which demanded distal landing in the other internal iliac artery.A gore® excluder® iliac branch endoprosthesis internal iliac component (hgb device) was placed first and then extended with a gore® viabahn® vbx balloon expandable endoprosthesis.It was stated that the result looked good at perioperative angiography imaging.Reportedly, on (b)(6) 2021, 30 days after implant, the internal iliac artery is occluded.It was reported that the patient presented with buttock pain which is persisting.It was reported that no reintervention was performed.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13605089
• MDR Text Key: 290800104
• Report Number: 2017233-2022-02769
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• 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: 09/13/2022
• 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
• Patient Sex: Male