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

Model Number BXA085902A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.As the device was not returned, no evaluation of the device could be performed.

Event Description

On (b)(6) 2020, the patient was being treated for stenosis in the common iliac artery using gore® viabahn® vbx balloon expandable endoprosthesis.It was reported the device met resistance as it was being advanced through the sheath.The device was removed from the patient.Next the device was advanced successfully through the sheath.It was reported as the device was being advanced to its intended location resistance was met and the stent was dislodged from the catheter.The physician stated it is unknown what caused the stent to become dislodged from the catheter.Another device was used to complete the procedure.A cut down procedure was performed to remove the device from the patient's common iliac artery.The patient tolerated the procedure.

Manufacturer Narrative

Method code 2 (4115) engineering evaluation task was performed and the results are: the device was identified to be an 8 x 59 mm configuration, which matches the event description.The gore® viabahn® vbx balloon expandable endoprosthesis returned without the delivery system.The catheter length was unable to be confirmed.The dislodged endoprosthesis was observed to be crushed.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Event Description

On (b)(6) 2020, the patient was being treated for stenosis in the common iliac artery using gore® viabahn® vbx balloon expandable endoprosthesis.It was reported the device met resistance as it was being advanced through the sheath.The device was removed from the patient.A second attempt to advanced the same device through the sheath was successful.It was reported as the device was being advanced to its intended location resistance was met and the stent was dislodged from the catheter.The physician stated it is unknown what caused the stent to become dislodged from the catheter.Another device was used to complete the procedure.A cut down procedure was performed to remove the device from the patient's common iliac artery.The patient tolerated the procedure.

Manufacturer Narrative

Corrected b5: event description.Corrected h10/11 method code.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis warnings section state: do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.

• 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: 9914281
• MDR Text Key: 194013447
• Report Number: 2017233-2020-00225
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00733132637331
• UDI-Public: 00733132637331
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: BXA085902A
• Device Catalogue Number: BXA085902A
• Device Lot Number: 21636457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• 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
• Patient Age: 79 YR
• Patient Weight: 87