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

Catalog Number	BXA062901A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The doctor reported the following to the gore fsa: the patient presented for a modified fenestrated aortic case.After the fenestration was created and the wire placed in the right renal, the doctor was unable to advance the gore® viabahn® vbx balloon expandable endoprosthesis (vbx), using a 7fr sheath, through the fenestrated hole.The doctor pulled the vbx back into the sheath and observed that the stent had dislodged from the balloon.The dislodged stent was jailed above the celiac artery behind the tevar.
Additional Manufacturer Narrative
Concomitant medical products and therapy dates/exclude treatment of event - cook zfen graft.
Additional Manufacturer Narrative
Corrected data: h6.- method code 2.
Additional Manufacturer Narrative
Additional manufacturer narrative: the complaint was for a stent dislodging from the delivery system balloon while attempting to advance the vbx through a fenestrated hole of a cook zfen device into the right renal artery.After resistance, it was reported that the device was attempted to be pulled back into the introducer sheath when the dislodgement occurred.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use warning section states, ¿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¿.Based on the engineering evaluation, no product design or manufacturing anomalies were detected.
Additional Manufacturer Narrative
Additional manufacturer narrative: d11.Concomitant medical products and therapy dates.
Additional Manufacturer Narrative
Corrected data: h10/11: review of the manufacturing records verified that the lot met release requirements.Additional manufacturer narrative: g5: pre-1938.G5: otc product.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8946050
• Report Number: 2017233-2019-00767
• Device Sequence Number: 19444081
• Product Code: NIO
• UDI-Device Identifier: 00733132637461
• UDI-Public: 00733132637461
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/14/2019

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: 02/24/2022
• Device Catalogue Number: BXA062901A
• Device Lot Number: 20601917
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/30/2019; 10/24/2019; 10/28/2019; 11/11/2019; 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK ZFEN GRAFT; COOK ZFEN GRAFT
• Patient Age: 58 YR