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

Model Number	BXA085902A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
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.Review of device manufacturing record history to confirm device met pre-release specifications is currently in progress.Device remains implanted; therefore, direct product analysis is not possible.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis directions for use state: device tapering may be performed by first deploying the device to the smaller of the two reference vessel diameters and subsequently post-dilating the device in the region of the larger reference vessel diameter.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.
Event or Problem Description
After an aortic case was completed, the physician treated an iliac artery aneurysm that was near the bifurcation.An 8 x 39 gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was deployed and post dilated with a 10mm balloon.To extend the first device proximally, an 8 x 59mm vbx device was advanced and deployed.However, it was found this device did not have enough wall apposition after the ballooning was completed.When the balloon catheter was withdrawn, the deployed vbx device migrated to the distal end of the first device.The 8x59 vbx device landed with good wall apposition in the external iliac artery.The physician elected not to place any other devices as the hypogastric artery maintained good blood flow.As reported, there were no adverse consequences for the patient.
Additional Manufacturer Narrative
H6 - code 213: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code 4117: the device is not accessible for testing as it remains in the patient.However, an engineering evaluation was conducted with the following results: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Radial strength of the vbx device can be influenced by the stent ring material, stent ring geometry, stent ring spacing, and stent ring alignment.The stent rings are certified by the supplier for the material and geometric properties.Stent rings are 100% verified during the manufacturing process to be free of visual deformities.Stent ring geometry, spacing, and alignment are 100% verified during the manufacturing process.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.D1 and d2 were updated with corrected information.G4 was updated with correct number.

• 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: 10702329
• Report Number: 2017233-2020-01369
• Device Sequence Number: 13757877
• Product Code: PRL
• UDI-Device Identifier: 00733132637331
• UDI-Public: 00733132637331
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 02/14/2023
• Device Model Number: BXA085902A
• Device Catalogue Number: BXA085902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR