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

Catalog Number BXA077901J

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Occlusion (1984)

Event Date 06/18/2020

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2020, this patient underwent endovascular treatment using three gore® viabahn® vbx balloon expandable endoprosthesis for leriche syndrome.Two vbx were deployed in the aortic bifurcation using the kissing stent technique.The third vbx was deployed to extend the left device distally.The patient tolerated the procedure.On (b)(6) 2020, a follow-up imaging examination revealed the vbx device implanted on the patient¿s right side of the aortic bifurcation had collapsed.The physician¿s stated the suspected cause of the collapse is unknown.On (b)(6) 2020, the patient underwent a reintervention to treat the collapsed device.The right vbx was relined using bare stent.It was reported that the left vbx was patent without any issues.The patient tolerated the procedure.

Manufacturer Narrative

H6: corrected conclusion code 4315.

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.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.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: STENT, ILIAC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10260689
• MDR Text Key: 199704412
• Report Number: 2017233-2020-01022
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Catalogue Number: BXA077901J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 87 YR