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

Catalog Number BXAL087902E

Device Problems Difficult to Advance (2920); Premature Separation (4045)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

On unknown date the patient underwent an endovascular aortic repair for an abdominal aortic aneurysm that was treated with an unknown endovascular graft.On unknown date the patient presented with a degeneration of the common iliac artery leading to an endoleak type 1b.Therefore, on (b)(6) 2022.The patient underwent an endovascular reintervention to treat the endoleak with a gore® excluder® iliac branch endoprosthesis (ibe device) placed in the common iliac artery and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) placed in the internal iliac artery.After implantation of the ibe device the vbx device was advanced over a 0.035¿ rosen wire guide (cook medical) inside a 16 fr steerable sheath (aptus) with 22 mm deflected tip reach from the contralateral right common femoral artery.The sheath was introduced up to the flow divider of the trunk of the previously implanted excluder device and then it was deflected 180°.Reportedly the tip of the sheath was positioned right below the renal arteries quite far away from the internal iliac artery.Reportedly, the vbx device was advanced through the sheath, and they managed to advance it outside the sheath, but it would not go further down towards the internal iliac artery.It could not be clarified if high force was required to advance the vbx device through the sheath.Therefore, they retrieved the vbx device back into the still deflected part of the sheath and tried to withdraw the vbx device through the sheath because the physician thought that this would be better than removing everything together in the present situation.Reportedly no high force was applied during retraction of the vbx device.It was reported that when the vbx device was half the way through the sheath fluoroscopy showed that the endoprosthesis was displaced from the markers.Finally, the endoprosthesis came off the delivery catheter inside the sheath and got stuck inside the handle of the sheath.This was confirmed by the physician using fluoroscopy.To remove the endoprosthesis they finally removed the sheath together with the endoprosthesis in a unit.The physician suspects that several factors might have contributed to the advancement failure of the endoprosthesis: the tip of the sheath was quite far away from the internal iliac artery, the sheath was deflected 180°, and the guidewire support of the vbx device might have been too little.Therefore, the vbx device was barely maneuverable.The physician has no suspects as to why the endoprosthesis has dislodged from the delivery catheter.Because of the experienced difficulties to advance the vbx device using an up-and-over approach they then changed to a brachial access and implanted a new gore® viabahn® vbx balloon expandable endoprosthesis successfully.Reportedly the patient tolerated the procedure and is doing well.

Manufacturer Narrative

(b)(4).Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Code b01, c19, d12, d15 and d1102: the returned device was visually inspected.The evaluation confirms stent dislodgement; however, the reported advancement and withdrawal difficulties are unable to be confirmed from the device evaluation.An attempt at replicating the incident to further understand the failure was not pursued because the state of the device is no longer representative of how it would have been received by the user, and the conditions present during the procedure could not be recreated.The cause for the dislodgement is attributed to an unintended use error because the instruction for use states, "do not attempt to pull an endoprosthesis system that has been either partially expanded or not expanded back into the introducer sheath, as dislodgement of the endoprosthesis from the balloon may occur.".

• 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: 15018837
• MDR Text Key: 296782237
• Report Number: 2017233-2022-03122
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Male