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

Catalog Number BXAL085902E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Patient height: 163 cm.Dicom imaging datasets were requested from the study coordinator for evaluation.Answer pending.The device remains implanted in the patient.A review of the manufacturing records indicated the device met pre-release specifications.The device remains implanted in the patient, therefore an engineering evaluation could not be performed.

Event Description

On (b)(6) 2019, the patient underwent a luminal reconstruction of an arteriovenous fistula in the subclavian vein, because of a stenosis/occlusion of a previously implanted vascular graft (non-gore device).The stenosis/occlusion was treated with a gore® viabahn® vbx balloon expandable endoprosthesis.Access was gained via the right median basilica vein to implant the viabahn® vbx endoprosthesis.The study database indicates that the viabahn® vbx device was successfully placed and deployed as intended without abnormalities noticed.The viabahn® vbx device was patent at the end of the procedure.Reportedly, on (b)(6) 2019, the patient present with an occlusion of the viabahn® vbx endoprosthesis.The physician stated, that the occlusion remained and the clinical case was resolved by constructing a new arteriovenous fistula in the contralateral limb during a reintervention on (b)(6) 2019.

Manufacturer Narrative

H6-code 4111: dicom imaging datasets were requested from the study coordinator for evaluation.H6-code 213: the requested dicom imaging datasets were not provided, therefore an imaging evaluation could not be performed.

Manufacturer Narrative

Code 4111: dicom imaging datasets were requested from the study coordinator for evaluation.Code 213: the requested dicom imaging datasets were not provided, therefore an imaging evaluation could not be performed.

• 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: 9898348
• MDR Text Key: 195284617
• Report Number: 2017233-2020-00217
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Catalogue Number: BXAL085902E
• Device Lot Number: 20382518
• 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
• Patient Age: 55 YR
• Patient Weight: 58