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

Catalog Number	BXA072902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.Examination of the returned device revealed the following: no delivery system was provided and only a stent was received; the stent displayed visible damage to the rings.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported by the fsa: the physician was attempting to deliver the gore® viabahn® vbx balloon expandable endoprosthesis over a rosen wire into the celiac artery using a tour guide steerable sheath(groin approach).The tour guide kicked out of the celiac artery and the physician could not get the tour guide back into the celiac artery.The gore® viabahn® vbx balloon expandable endoprosthesis was advanced back and forth trying to get into the celiac artery but it kept hitting the cook fenestrated aaa graft.Then the gore® viabahn® vbx balloon expandable endoprosthesis went into the celiac artery but it came off the catheter during manipulation.The gore® viabahn® vbx balloon expandable endoprosthesis was now halfway in the celiac artery and the aorta.The physician used a snare to capture and removed the gore® viabahn® vbx balloon expandable endoprosthesis without any consequence to the patient.

• 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: 8440211
• Report Number: 2017233-2019-00158
• Device Sequence Number: 3056838
• Product Code: NIO
• UDI-Device Identifier: 00733132637515
• UDI-Public: 00733132637515
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 02/22/2019

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: 10/18/2021
• Device Catalogue Number: BXA072902A
• Device Lot Number: 20080050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other