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

Model Number	BXA115902A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2022, the patient underwent a procedure to expanded a collapsed previously implanted stent graft in the patients iliac artery using a gore® viabahn® vbx balloon expandable endoprosthesis.A glidewire.035 wire was used during the procedure.The device was advanced and met resistance due to tortuosity in the iliac artery.The device was attempted to be withdrawn through the sheath, however, the device would not withdraw through the 8fr sheath (brand unknown).The stent graft was detached from the catheter in the common iliac artery.A cut down was performed to retrieve the device.Another gore device was used to complete the procedure.The patient tolerated the procedure.
Additional 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.
Additional Manufacturer Narrative
Final report h10/11: section h6 updated to reflect completion of investigation: the device was returned to gore for evaluation.The vbx delivery system was returned undeployed, with no endoprosthesis present.The returned vbx device was confirmed as a gore® viabahn® vbx balloon expandable endoprosthesis device (11 x 59 mm endoprosthesis, with 135 cm delivery system).The endoprosthesis was returned separated from the delivery system.Witness marks, i.E., an impression from the previously placed endoprosthesis, are visible on the balloon cover.The delivery system was otherwise unremarkable.One end of the endoprosthesis was observed to have flared, overlapping, delaminated, crushed and bent rings.The cause of the stent displacement and associated damage to the endoprosthesis could not be established.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.¿.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13455785
• Report Number: 2017233-2022-02715
• Device Sequence Number: 5893543
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: BXA115902A
• Device Catalogue Number: BXA115902A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 68 KG