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

Catalog Number BXAL087902E

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Event Description

The patient was treated for aortic and iliac aneurysms using endovascular techniques.The patient previously underwent multiple thoracic endovascular aortic repair procedures and a concomitant endovascular aorto-iliac repair procedure.On (b)(6) 2021, the patient underwent a further endovascular aortic repair procedure with a customized t-branch device (cook medical).A gore® viabahn® vbx balloon expandable endoprosthesis (viabahn® vbx device) was used as a bridge stent-graft to the mesenteric artery.The physician positioned a 9f fustar¿ steerable introducer (55 cm, lifetech scientific) with 160° curvature in the customized t-branch device already implanted and cannulated the superior mesenteric artery (sma) through the dedicated branch with a 0.035'' rosen guidewire (cook medical).Then he advanced the viabahn® vbx device ((b)(4)) inside the steerable introducer sheath reaching the sma.Reportedly, the physician then decided to withdraw viabahn® vbx device ((b)(4)) without delivering it since it appeared too long.It was stated that he didn't remove the steerable introducer sheath together with the viabahn® vbx device ((b)(4)) in a tandem to maintain the access to the target vessel.Reportedly, the physician felt little resistance during retraction of viabahn® vbx device ((b)(4)).He noted that "the 9f fustar¿ steerable introducer was really stressed with 160° curvature".He stated that viabahn® vbx device ((b)(4)) didn¿t entangle with the tip of the 9f fustar¿ steerable introducer during retraction.It was stated that the physician then advanced another viabahn® vbx device ((b)(4)) through the same steerable introducer sheath, but he felt a big resistance at the tip of the steerable introducer sheath and, when pushing the delivery system, the catheter outside the patient kinked.Therefore, he withdrew also this viabahn® vbx device ((b)(4)) from the patient.At this stage of the procedure the physician got aware that something might be obstructing the tip of the steerable introducer sheath.He checked the delivery system of the viabahn® vbx device ((b)(4)) and noticed that the endoprosthesis was not on its balloon.It must have separated from the balloon during withdrawal and got stuck inside the tip of the steerable introducer sheath.It was reported that then the physician inserted a small armada¿ percutaneous transluminal angioplasty catheter (4 mm x 60 mm, abbott) into the steerable introducer sheath, caught the stuck endoprosthesis ((b)(4)) and removed it from the patient together with the steerable introducer sheath in a tandem.Reportedly the physician successfully completed the procedure using another viabahn® vbx device which was advanced through a 10fr fustar¿ steerable introducer (55 cm, lifetech scientific).

Manufacturer Narrative

Requests were emailed to the physician to provide patient information more details about the event.The answers were captured in the event description.Patient information like id, age, dob and gender, was requested but was not disclosed to gore because of privacy law.Therefore the gore reference number was used as the patient id.A review of the manufacturing records indicated the device met pre-release specifications.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

H6: code 213: the device was returned to w.L.Gore & associates for investigation.The product evaluation summary states the following: the returned device was confirmed to be an endoprosthesis from a gore® viabahn® vbx balloon expandable endoprosthesis device.The exact size of the endoprosthesis could not be determined by physical evaluation of the endoprosthesis alone; it could be either an 11 x 79 mm endoprosthesis, or an 8l x 79 mm endoprosthesis, as they appear physically similar on inspection.In the complaint description it was reported an 8l x 79mm vbx device was used in the procedure.The vbx delivery system was not returned.The endoprosthesis appeared to be partially expanded in rings 6-9, and the first stent ring was observed to have a bent apex.The root cause of the dislodgement of the endoprosthesis could not be established.

Manufacturer Narrative

Investigation conclusion: the root cause of the dislodgement of the endoprosthesis could not be established during device evaluation, gore requested further information however no further information was provided.Based on the event description and the subsequent investigation, the most probable root cause of the reported complaint might be associated to the following reasonably foreseeable misuse: user tries to remove delivery system through the introducer sheath with endoprosthesis still mounted leading to the potential for endoprosthesis migration.The cause of the reported device failure mode, endoprosthesis loses retention to the delivery system, could not be confirmed but is consistent with this reasonably foreseeable misuse.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) was reviewed with respect to the complaint detail and there are applicable warnings related to choosing the appropriate size device: ¿special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.¿ 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.¿ in addition, the following instruction is provided in the ifu: ¿do not attempt to pull an endoprosthesis system that has been either partially expanded or not expanded back into the sheath or guide catheter, as dislodgement of the endoprosthesis from the balloon may occur.Carefully observe the endoprosthesis for stent dislodgement or movement while attempting to withdraw the undeployed stent back through the sheath.¿.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13059688
• MDR Text Key: 282719041
• Report Number: 2017233-2021-02629
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXAL087902E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose