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

Catalog Number BXA085902E

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Premature Separation (4045)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

The patient underwent a complex branched endovascular aortic repair with a zenith® t-branch thoracoabdominal endovascular graft (cook medical).Access was gained from the common femoral artery.After the aortic device was implanted the physician positioned a 9 fr fustartm steerable introducer sheath (55 cm, lifetech scientific) in the aortic device and cannulated the celiac trunk through the dedicated branch with a 0.035'' rosen guidewire (260 cm, cook medical).Reportedly the anatomy was not very tortuous, but retrograde cannulation of the celiac trunk required an extreme curvature of the introducer sheath of 150°.An 8 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used as a branch device to the celiac trunk.Reportedly vbx device and introducer sheath were prepared according to their instructions for use.The vbx device was advanced through the introducer sheath and beyond.It was reported that then the guidewire slipped out of the celiac trunk and cannulation was lost.Reportedly it was not possible to further advance the vbx into the celiac trunk without guidewire in place.Therefore, it was necessary to remove the vbx device from the patient.It was reported that the physician wanted to maintain access.Therefore, he withdrew the vbx device through the introducer sheath, instead of removing it with the introducer sheath in tandem.The physician reported that he felt big resistance at the tip of the introducer sheath during retraction of the vbx device.Eventually the endoprosthesis dislodged from the balloon delivery catheter during retraction inside the introducer sheath.The physician said that he was also aware that he stressed the vbx device because of the 150° curvature of the introducer sheath, reportedly he felt friction along this curvature during retraction of the vbx device.He said that in summary friction and curvature might have led to the dislodgement of the endoprosthesis.Reportedly the endoprosthesis remained inside the introducer sheath.Therefore, the physician was able to remove introducer sheath and endoprosthesis from the patient as a unit without any adjunctive procedure.To complete the procedure the physician used a new introducer sheath and the same guidewire to implant a new gore® viabahn® vbx balloon expandable endoprosthesis device (9 mm) without any further complication.Reportedly the procedure took 5-10 minutes longer due to introducer sheath replacement and re-cannulation of the celiac trunk.It was reported that there was no harm or injury to the patient because of the reported issue.

Manufacturer Narrative

Device evaluated by mfr: the device is being returned for evaluation.(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.

Manufacturer Narrative

Patient information: patient information was requested but could not be obtained.H6: code 10 and 3207: the device was returned to for investigation.The product evaluation summary states the following: the returned device was confirmed as a gore® viabahn® vbx balloon expandable endoprosthesis device (8 x 59 mm endoprosthesis, 135 cm delivery system).No accessory devices, including the introducer sheath used, were returned.The device was returned undeployed with the stent partially mounted but displaced distally by approximately 24 mm.This observation is consistent with reported stent dislodgement during device withdrawal through the sheath.The balloon cover was observed to bear witness marks from its original position on the delivery system following manufacturing and final inspection.No further remarkable observations were noted with respect to the endoprosthesis or delivery system.H6: code 61: the reported failure mode, endoprosthesis loses retention to delivery system, was confirmed during evaluation of the device.The physician reported withdrawal of the vbx device through the introducer sheath instead of removal with the introducer sheath in tandem as indicated in the ifu.Therefore, the root cause is consistent with reasonably foreseeable misuse in the reported attempt to remove the delivery system with the stent still mounted through the sheath leading to the potential for stent migration.The physician also indicated friction and extreme curvature of the introducer sheath as contributing factors in device dislodgement.H6: code 22: 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.¿should it become necessary to remove either a partially expanded or non-deployed gore® viabahn® vbx balloon expandable endoprosthesis from the vessel, do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath after the endoprosthesis is fully introduced.To remove the gore® viabahn® vbx balloon expandable endoprosthesis, it can be withdrawn 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.¿ the ifu proceeds to state: ¿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.¿.

Manufacturer Narrative

H6: all codes were update to mapped imdrf code.Codes for entrapment of the device (a150208) and confirmed device migration (c0701) have been added.Investigation results and conclusion remain unchanged.H6: code 2820 was replaced with a150207.H6: code 61 was replaced with d1108.

• 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: 14553477
• MDR Text Key: 293365344
• Report Number: 2017233-2022-02973
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA085902E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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 Outcome(s): Hospitalization