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

Model Number BXA115902A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Aneurysm (1708)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Patient comorbidities: previous smoker, hypertension, and previous aaa.Patient medications: aspirin and ramipril.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) states after deploying the endoprosthesis, slowly withdraw the balloon.Observe under fluoroscopy the balloon is fully deflated prior to removal.Also if resistance is encountered upon attempted removal, do not force removal.

Event Description

On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.It was reported that the right common iliac artery had become aneurysmal due to the contralateral leg endoprosthesis losing seal distally and a distal type i endoleak (date and modality of images is unknown).The physician reintervened on (b)(6) 2020 and implanted a gore® excluder® iliac branch endoprostheses and a gore® viabahn® vbx balloon expandable endoprosthesis.The endoleak was resolved.While retracting the delivery catheter (from the left brachial artery access) of the vbx, it was difficult to deflate the balloon.It was revealed that the technician put too much contrast mixed with saline to inflate the balloon, reportedly this makes it difficult to deflate the balloon.By mistake, the technician added additional contrast, as opposed to saline to the balloon.So with the balloon being not fully deflated the physician became impatient and attempted to yank the delivery catheter through the terumo destination sheath (8fr x 90cm in the brachial artery).Upon doing so, the hub of the balloon separated from the shaft of the catheter (2203-a).The physician was able to get both pieces into the sheath and then removed the sheath.There was no serious injury to the patient.The patient tolerated the procedure.

Manufacturer Narrative

Addition d4.Addition d8.Addition g4.Addition -the device was returned to gore for an engineering evaluation.The device was identified to be an 11 x 59 x 1350 mm configuration, which matches the event description.The gore® viabahn® vbx balloon expandable delivery system was returned with the hub detached and without the endoprosthesis mounted on it because it was successfully deployed.The delivery catheter displayed necking from the separation to 10cm down the length of the delivery system.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.Addition cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is 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: 10702147
• MDR Text Key: 217673457
• Report Number: 2017233-2020-01367
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2022
• Device Model Number: BXA115902A
• Device Catalogue Number: BXA115902A
• Device Lot Number: 21783871
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 79