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

Catalog Number	BXAL082902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.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 to gore: the patient presented with a left subclavian lesion.The gore® viabahn® vbx balloon expandable endoprosthesis was advanced through the 7fr tuermo sheath to the un-dilated lesion.When the device could be advanced no more the doctor elected to remove the device.As the doctor was withdrawing the device, he was unable to get it into the sheath.The device 'popped' off the catheter in the patient.The doctor was able to snare the device out of the patient.The procedure continued with the doctor pre-dilating the lesion and implanting another gore® viabahn® vbx balloon expandable endoprosthesis successfully.

• 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: 8647440
• Report Number: 2017233-2019-00376
• Device Sequence Number: 2267962
• Product Code: NIO
• UDI-Device Identifier: 00733132637805
• UDI-Public: 00733132637805
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 12/03/2021
• Device Catalogue Number: BXAL082902A
• Device Lot Number: 20045913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• 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: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR