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

Model Number	BXA075902A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.As the devices were not returned, no evaluation of the devices could be performed.
Event or Problem Description
On (b)(6) 2020, the patient was being treated an unknown etiology using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).On (b)(6) 2020, the patient presented to the hospital for follow-up.It was reported a possible infection of the vbx was identified.It is unknown if the infection is attributable to a pre-existing infection in field of treatment.An additional zilver stent was implanted extending from the vbx.The physician is going to monitor the patient.
Additional Manufacturer Narrative
Added h6: method 4117 - device not accessible for testing.
Additional Manufacturer Narrative
Code 213 ¿ the review of the sterilization paperwork verified that this lot met all pre-release specifications.

• 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: 9866348
• Report Number: 2017233-2020-00207
• Device Sequence Number: 19629074
• Product Code: NIO
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: BXA075902A
• Device Catalogue Number: BXA075902A
• Device Lot Number: 21363192
• 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
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/20/2020; 04/20/2020
• 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: Hospitalization; Required Intervention