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

Catalog Number BXAL085901J

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be conducted since the requested lot number is not available.As the devices were not returned, no evaluation of the devices could be performed.

Event Description

On (b)(6) 2019, the patient underwent an endovascular procedure to repair occlusion of the right and left common iliac arteries.It was reported that the bilateral common iliac arteries were calcified.Three gore® viabahn® vbx balloon expandable endoprostheses were placed with covered endovascular reconstruction of the aortic bifurcation (cerab) technique, one in the abdominal aorta, one in the right common iliac artery and one in the left common iliac artery.It was reported that gore® viabahn® vbx balloon expandable endoprosthesis in the right side was expanded to 8mm.The patient tolerated the procedure.On november 27, 2019, post-operative follow-up imaging revealed distal portion of gore® viabahn® vbx balloon expandable endoprosthesis in the right common iliac artery was reportedly compressed.On (b)(6) 2019, re-intervention was performed.It was confirmed that the diameter of the right common iliac artery was approximately 12mm-14mm.The gore® viabahn® vbx balloon expandable endoprosthesis in the right common iliac artery was reportedly expanded to 12mm using a 12mm armada pta balloon catheter.Intra-operative imaging showed adequate blood flow through the gore® viabahn® vbx balloon expandable endoprosthesis.It was reported the gore® viabahn® vbx balloon expandable endoprosthesis was suspected to have compressed due to external pressure.It was also reported that gore® viabahn® vbx balloon expandable endoprosthesis wasn¿t expanded to the diameter of the right common iliac artery during initial procedure.Reportedly, the physician suspected that may have contributed to the event.

Manufacturer Narrative

The engineering evaluation states the following: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.The complaint was for a compressed device.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 examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Corrected h1.Type of reportable event (serious injury).

Manufacturer Narrative

The referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.The complaint was for a compressed device.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.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Corrected conclusion code 1: 61.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9566393
• MDR Text Key: 197165945
• Report Number: 2017233-2020-00014
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXAL085901J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2020; 02/14/2020; 02/14/2020; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR