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

Model Number BXA077902A

Device Problem Fracture (1260)

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

Event Date 10/12/2020

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.Review of device manufactory record history confirmed device met pre-release specifications.The endoprosthesis was deployed and remains in patient.The delivery catheter was returned and results are pending on completion of investigation.

Event Description

During a complex thoracoabdominal aneurysm procedure, a 7fr cook sheath was used to advance a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) to the superior mesenteric artery.As reported, the patient has a very tortuous anatomy.The vbx device was placed and deployed at the intended treatment site with no issues.However, upon withdrawal of the delivery catheter over the.035 rosen wire the proximal part of the vbx catheter just below the hub tore apart from the rest of the catheter.The entire sheath with the broken vbx delivery catheter inside, was withdrawn from the patient as one unit.The sheath was then replaced with an 8fr terumo sheath and a new device was placed.The procedure ended with good results.The patient did not experience any adverse consequences.

Manufacturer Narrative

Patient age and weight were requested but not made available.Code 213: engineering evaluation: the returned specimen was identified to be a 7 x 79 x 1350 mm configuration, which matches the event description.The gore® viabahn® vbx balloon expandable delivery system was returned with the hub detached and the catheter stuck within a non-gore introducer sheath.Because the sheath is not a gore product it was not evaluated.The delivery catheter displayed two kinks as well as a 7cm section of necking beginning at the separation point.The delivery catheter lot met specifications for tensile strength.The catheter of the vbx delivery system is 100% inspected at the end of the manufacturing process for any mechanical damage, including necking.Any devices with mechanical damage are rejected.The device history file did not indicate any anomalies occurred that would increase the force to withdraw the device.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: 10804578
• MDR Text Key: 217672996
• Report Number: 2017233-2020-01423
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• 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: 02/15/2021

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 Expiration Date: 07/18/2022
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 02/15/2021
• Patient Sequence Number: 1