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

Catalog Number BXA067901J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 07/26/2020

Event Type  Injury  

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.

Event Description

The following information was reported to gore: on (b)(6) 2020, a patient underwent endovascular treatment of an abdominal aortic aneurysm, and two gore® viabahn® vbx balloon expandable endoprostheses were placed at right renal artery using snorkel/chimney technique.The procedure was completed without any issue.On (b)(6) 2020, it was revealed both vbx devices were occluded.Thrombus aspiration and poba were performed.During the reintervention it was observed that the vbx was kinked at the origin of the right renal artery.The patient tolerated the procedure.The physician reported that the origin of the right renal artery was tortuous, therefore, the vbx might have been compressed.During the initial procedure, a stiff guidewire was used, so the artery was temporarily straightened.Angiography during the initial procedure did not identify compression of either of the vbx.

Manufacturer Narrative

H6: code 213 ¿ the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

Corrected c1; corrected d1/d2; corrected h6 conclusion code.Engineering evaluation: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Crush resistance of the vbx device can be influenced by the stent ring material, stent ring geometry, stent ring spacing, and stent ring alignment.The stent rings are certified by the supplier for the material and geometric properties.Stent rings are 100% verified during the manufacturing process to be free of visual deformities.Stent ring geometry, spacing, and alignment are 100% verified during the manufacturing process.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 10434830
• MDR Text Key: 203836407
• Report Number: 2017233-2020-01137
• 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
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: BXA067901J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention