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

Catalog Number BXA115902E

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

As the device remains implanted, no further investigation can be performed on the device.The delivery system was returned and an engineering evaluation will be performed.(b)(4).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 for an aneurysm of the left common iliac artery (cia) with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that an iliac branch procedure was performed on the left side in an existing abdominal aortic aneurysm (aaa).The iliac branch endoprothesis (ibe) main body was placed from the left side without any problems.Due to the aaa in place axial access with a 10fr dryseal sheath was performed.The vbx-device bxa115902e was inserted over a cook rosen guide wire but became stuck at the level of the internal iliac gate of the iliac branch component (ceb) due to massive friction.It was reported that it was not possible to advance the vbx-device in the internal iliac gate.So, the product was pulled back to place the cook rosen guide wire deeper in the vessel.By pulling back, the vbx-device slipped off the balloon when pulled into the 10fr sheath.It was stated that the balloon was removed without the vbx-device.The vbx-device - still on the guidewire - was secured with the contralateral leg endoprosthesis plc231200 from the left side in the existing extension of the aaa.Reportedly, the left internal iliac artery (iia) was cannulated again.Over a new cook rosen guide wire another vbx-device bxa115902e was inserted.It was no problem to bring this product at the desired position and it could be implanted without any problems.The patient is doing fine.

Manufacturer Narrative

Engineering evaluation: the returned device was confirmed as the delivery system (135 cm) for a gore® viabahn® vbx balloon expandable endoprosthesis (11 mm x 59 mm) device.The vbx delivery system was returned undeployed, with no endoprosthesis present.Witness marks, i.E., an impression from the previously placed endoprosthesis, are visible on the balloon cover.The delivery system was otherwise unremarkable.The cause of the stent dislodgement could not be established.No further information was provided to gore to what could have caused the massive friction during advancement of the endoprosthesis.As the device remains implanted and no images are available no further investigation can be performed.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements.The ifu provides instruction that if excessive resistance is felt, the delivery catheter and sheath be removed together as a unit: ¿using fluoroscopic guidance, advance the delivery catheter over the guidewire via the angiographic sheath.Advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery catheter and sheath together as a unit.¿ the ifu also warns of the potential for stent dislocation when withdrawing the undeployed vbx device back into the sheath: ¿do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and/or damage to the endoprosthesis, premature deployment, deployment failure, and/or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.¿.

Manufacturer Narrative

H6: evaluation codes investigation conclusions: code 18 failure to follow instructions was removed.

• 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: 12581709
• MDR Text Key: 275008965
• Report Number: 2017233-2021-02440
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Catalogue Number: BXA115902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: CONTRALATERAL LEG ENDOPROSTHESIS ILIAC BRANCH END.; CONTRALATERAL LEG ENDOPROSTHESIS ILIAC BRANCH END
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 97 KG