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

Catalog Number BXA085902E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Renal Impairment (4499)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, an investigation on the device cannot be performed.(b)(4).A review of the manufacturing records indicated the device met pre-release specifications.Images were requested and provided and an imaging evaluation will be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment in the left kidney with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that the chimney technique was used with a medtronic endurant¿ ii graft as main body.The vbx-device was advanced into the left kidney through a 7fr terumo destination sheath.It was reported that when the sheath was withdrawn, the stent was displaced distally from the balloon.After the balloon had been dilated and the vbx-device was released, an approximately 5 mm long part ("nose") remained, which had not flared up.It was stated that this "nose" should be flared by repositioning the deflated balloon and its re-inflation.However, the balloon could not be repositioned distally.Reportedly the flow in the remaining kidney is poor and insufficient.

Manufacturer Narrative

Imaging evaluation: summary: ¿ one time point available for evaluation: selected (by site) angiogram imaging segments collected from an intra-operative angiogram procedure dated (b)(6) 2021.¿ imaging appears to demonstrate a stent that was implanted in the left renal artery appears to have the most distal portion of the device that is not fully expanded.¿ ballooning appeared to take place post implantation.¿ stent still does not appear to be fully expanded.¿ flow into the left renal stent and artery appears to be delayed in comparison to the aortic filling.Minimal flow density in the left renal artery compared to contrast filling density within the aorta.

Manufacturer Narrative

B1 and b2: this is a reportable malfunction (partial deployment) along with a serious injury.

Event Description

The following was reported to gore: a patient presented with an aortic abdominal aneurysm that was treated with a medtronic endurant¿ ii graft as a main body and using a chimney technique, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent) was implanted in the left renal artery.The vbx device was advanced to the target vessel through a 7 fr terumo destination sheath.After deployment, approximately 5 mm of the vbx stent was not fully expanded.As reported, the vbx device was placed correctly in the target vessel.The balloon might have slipped during inflation, possibly contributing to partial stent expansion.To address the partially expanded vbx stent, the plan was to inflate with a step by step, utilizing a mustang 6 x 40 balloon.However, the balloon was not able to reach the distal end of the vbx stent or inflate the folded part of vbx stent.At the end of the procedure there was insufficient blood flow in the renal artery.It has been reported to gore that the patient is on dialysis now.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12129191
• MDR Text Key: 264096101
• Report Number: 2017233-2021-02140
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2023
• Device Catalogue Number: BXA085902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC ENDURANT II, TERUMO DESTINATION SHEATH 7
• Patient Outcome(s): Other; Disability
• Patient Age: 75 YR
• Patient Sex: Male