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

Catalog Number BXA075901J

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Occlusion (1984)

Event Date 06/17/2020

Event Type  malfunction  

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.(b)(4).

Event Description

Following was reported to gore: in (b)(6), 2020, a patient underwent endovascular treatment of in-stent restenosis of the left common iliac artery using gore® viabahn® vbx balloon expandable endoprosthesis(vbx).The procedure was completed without any issues.Date unknown, it was confirmed that the vbx was compressed and was occluded by thrombosis.On (b)(6) 2020, reintervention placing two bare metal stents was performed.The intraoperative imaging confirmed blood flow, and the procedure was completed.After few days from the re-intervention of placing two bare metal stents, it was revealed the vbx was compressed again.Femoral-femoral bypass was performed.The patient tolerated the procedure.The physician reported that since the patient has scoliosis and a kyphotic spine, the vbx in the common iliac artery became externally compressed.After f-f bypass, the patient was doing well.

Manufacturer Narrative

H6.Results code 2: 213: 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: 10568069
• MDR Text Key: 207992106
• Report Number: 2017233-2020-01279
• 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
• Report Date: 03/30/2021

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
• Device Expiration Date: 09/14/2022
• Device Catalogue Number: BXA075901J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 90 YR