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

Model Number BXA082901A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Request was made for device return.However, device was retained by user facility for their investigation.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis state: 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.Directions for use: it is recommended to pre-dilate the lesion to allow for easy passage of the gore® viabahn® vbx balloon expandable endoprosthesis.Prior to opening the sterile package, check that the diameter and length of the endoprosthesis as well as the delivery catheter length are correct before removing from the packaging.In selecting the appropriate size endoprosthesis, a careful assessment of the vessel is necessary.Stenotic or occlusive lesions: to reduce the potential for vessel damage, the final stent inner diameter (as indicated on the compliance chart) should approximate the diameter of the vessel just proximal and distal to the stenosis.To prevent endoprosthesis migration, care should be taken to ensure the device is sufficiently apposed to the vessel wall between initial device deployment and post-dilatation (if performed).The endoprosthesis lengths of the gore® viabahn® vbx balloon expandable endoprosthesis listed in table 1 are nominal.Wherever appropriate, it is recommended that the endoprosthesis overlap the native vessel at least 1 cm beyond the proximal and distal margins of the lesion when treating stenotic or occlusive lesions.Endoprosthesis foreshortening should be taken into account to achieve the recommended lesion coverage.Verify that there is sufficient catheter length to access the treatment site.

Event Description

The following was reported to gore via user facility mdr: on (b)(6) 2021, while placing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device), the vbx device became trapped in the stenosis of the superior mesenteric artery.As reported, the vbx device dislodged from the delivery system and attempts were made to re-position the vbx device with a partially inflated balloon.After the vbx device was snared, it could not be re-positioned to the intended treatment area without causing significant arterial injury.As a result, the vbx device was removed through open procedure.Access was made from right common femoral artery using ultrasound guidance.After a micropuncture set, upsizing to 6 french sheath was done.An omniflush catheter was advanced into the aorta and an aortogram was obtained.The sheath was exchanged for a 45cm 7fr conformable sheath which was advanced to the paravisceral aorta.With this sheath and a bern catheter, the celiac artery was accessed.A 7x22mm icast stent was put into position at the origin and deployed.The proximal end was flared in the aorta with a 9mm balloon.Angiogram showed good result at this location.The sheath was withdrawn back into the aorta and positioned to access the superior mesenteric artery (sma).The sma had a steep downward angle.The conformable sheath was put into position and with a bern catheter the sma was accessed.An 8 x 39mm vbx device was selected to land short of the first branch distal and have the proximal stent extend just into the aorta and flare.As reported, the stenotic area and the steep angle of artery made positioning difficult.The vbx device preferentially would move distal into the artery in a position where the first branch would occlude.On pulling it back the forces would pull the sheath too far into the proximal artery not giving the vbx device space to deploy.Decision was made to remove the vbx device and exchange it for a shorter one to allow for better maneuverability.In pulling the vbx device back into the sheath, the device slid off the delivery system and remained suspended in the proximal sma.As the wire was still in place an 8mm balloon was advanced into the vbx device.The vbx device was too far distal from whether deployment would have caused occlusion of the side branches.Consequently, the balloon was only partially inflated in order to capture and withdraw the vbx device to the origin of the vessel.The balloon got forced out proximal to the vbx device and could not re-advance it.A quickcross catheter was advanced beyond the vbx device and exchanged for a v14 wire.A 2.5mm balloon was advanced beyond the vbx device and inflated with plans to pull the vbx device back into the sheath and remove everything with the vbx device captured.The vbx device appeared to have been trapped in the stenosis and would not move.Without much force, the balloon pulled into the vbx device and then became dislodged from the catheter.When the catheter came back, wire access was lost.A second 0.014 wire was passed as a safety wire into the sma beyond the vbx device and balloon.A 10 en-snare was advanced and the vbx device was able to be snared.The same combination of forces, however, did not allow the vbx device to be retracted and it became clear the vbx device would not be able to pull the device out from the origin of the artery.Physician was also concerned that even if enough force was apply to remove the vbx device to the origin of the artery, it would cause significant arterial injury.As reported, pre-existing characteristics may have contributed to the adverse event.

Manufacturer Narrative

Investigation conclusion: the product was not returned for evaluation.The cause of the reported failure mode, covered stent dislodgement, could not be established with the information provided.The physician indicated in the complaint description that ¿the stenotic area and the steep angle of artery made positioning difficult¿ and that ¿patient condition and pre-existing characteristics may have contributed to the adverse event¿.Gore was not able to obtain any further details about further patient conditions or pre-existing characteristics that may have contributed to the adverse event.As reported in the complaint description, the vbx device became stuck in the stenotic occlusion and the endoprosthesis was dislodged from the delivery system during attempts to pull delivery system back into sheath.The cause of the reported reasonably foreseeable misuse cannot be confirmed.B1 - selected both h6 - codes added and/or updated.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12143874
• MDR Text Key: 262665953
• Report Number: 2017233-2021-02155
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637546
• UDI-Public: 00733132637546
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: BXA082901A
• Device Catalogue Number: BXA082901A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2020
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 72 KG