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

Catalog Number	BXA115901A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: a gore® viabahn® vbx balloon expandable endoprosthesis with heparin was inserted into an 8fr sheath without issue.The device was inflated and the stent deployed without issue.The balloon was deflated and pulled back to remove from patient.The physician met significant resistance trying to remove the catheter from the patient.During this resistance the catheter hub dislodged from the catheter.The wire and catheter were removed with no further issues.
Additional Manufacturer Narrative
Additional manufacturer narrative: gore has received additional information regarding the event originally reported.The additional information received confirms this event is not considered a malfunction and therefore is not a reportable event.The catheter hub dislodged from the catheter outside 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: 8356399
• Report Number: 2017233-2019-00093
• Device Sequence Number: 2198564
• Product Code: NIO
• UDI-Device Identifier: 00733132637737
• UDI-Public: 00733132637737
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 03/19/2019

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: 08/01/2021
• Device Catalogue Number: BXA115901A
• Device Lot Number: 18661989
• 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
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/20/2019
• 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