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

Model Number BXA075902A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 02/26/2020

Event Type  Injury  

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 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.

Manufacturer Narrative

Added h6: method 4117 - device not accessible for testing.

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
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9866348
• MDR Text Key: 191244412
• Report Number: 2017233-2020-00207
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention