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

Model Number BXA117901A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/06/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, the patient underwent aortoiliac stenosis repair using gore® excluder® iliac branch endoprosthesis (ibe) and extend into common iliac with gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The vbx met significant resistance passing through an 8fr terumo sheath, but was eventually in proper position and successfully deployed.When removing the vbx balloon catheter through the same sheath, we again met resistance even while pulling negative pressure on the balloon.The vbx catheter detached into multiple pieces.The sheath and catheter were pulled out in tandem, and another sheath was reinserted.The patient did not appear to suffer an adverse effect.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release specifications.The device was identified to be an 11 x 79 x 800 mm configuration, which matches the event description.The device arrived with an introducer sheath; however, because this is not a gore product it was not evaluated (mpdcase-00000184_engineering_image_1).The gore® viabahn® vbx balloon expandable delivery system returned without the endoprosthesis mounted on it because it was successfully deployed; however, the returned hub had separated catheter material making it detached from the rest of the delivery system (mpdcase-00000184_engineering_image_2).The delivery catheter displayed necking from the separation point to 0.5 cm, 1.5-4 cm, 5-6 cm, and damage from 31-31.5cm.The manufacturing process output of device profile can contribute to insertion difficulties.Device profile is 100% inspected during the manufacturing process.The device history file did not indicate any anomalies occurred that would alter the device profile.The delivery catheter lot met specifications for tensile strength.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.H6 evaluation codes - results and conclusions updates to reflect the evaluations that were performed.

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

• 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: 10317398
• MDR Text Key: 200427648
• Report Number: 2017233-2020-01047
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637751
• UDI-Public: 00733132637751
• 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: 02/25/2021

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: 02/14/2023
• Device Model Number: BXA117901A
• Device Catalogue Number: BXA117901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 02/25/2021
• Supplement Dates FDA Received: 12/16/2020; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR