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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.
Event or Problem Description
During an endovascular treatment for aneurysm and occlusion, an 8fr ansel sheath was placed inside a 12fr gore® dryseal flex introducer sheath that was going through a 16fr gore® dryseal flex introducer sheath.As reported, the iliac branch component of ibe and excluder c3 devices were placed.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was to be implanted in the internal iliac artery.With a buddy wire in place, the physician attempted to advance the vbx device up and over the c3 flow divider.However, the vbx device would not pass.Consequently, the physician decided to remove the vbx device in order to dilate the tight space with a pta balloon.During withdrawal of the vbx device, it got caught on 8fr sheath edge, dislodging the device from the catheter.The vbx device was able to be removed without a snare.A new vbx device was successfully implanted to complete the procedure.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
The device involved in this complaint was discarded at user facility.Therefore, direct product analysis could not be conducted.However, the manufacturing records were reviewed, and the device lot met all pre-release specifications.The as-reported complaint, related to the endoprosthesis dislodging from the catheter, is confirmed based on the complaint description.The complaint provides information regarding the sequence of actions during the procedure, and, considering warnings in the ifu, it is probable that cause of the dislodged endoprosthesis is related to use outside the device ifu.Instructions for use (ifu) for gore® viabahn® vbx balloon expandable endoprosthesis warning section 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.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
H6 - health effect - impact code was added.

• 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
• MDR Report Key: 10972456
• Report Number: 2017233-2020-01514
• Device Sequence Number: 2322774
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: BXA115902A
• Device Catalogue Number: BXA115902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 11/11/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 03/10/2021; 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 81