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

Catalog Number BXA075901J

Device Problems Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Premature Separation (4045)

Patient Problem Occlusion (1984)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The instructions for use, 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.

Event Description

The following was reported to gore: on (b)(6) 2018, the patient presented for endovascular repair of in-stent restenosis in the left external iliac artery using a gore® viabahn® vbx balloon expandable endoprosthesis.The gore® viabahn® vbx balloon expandable endoprosthesis would not advance past the narrowest portion of the previously implanted stent.During withdrawal, the gore® viabahn® vbx balloon expandable endoprosthesis was retracted but the device did not enter into the sheath.The doctor observed that the undeployed stent had separated from the catheter.A bare metal stent was implanted from inside the aorta to the right iliac to prevent migration of the gore® viabahn® vbx balloon expandable endoprosthesis.On (b)(6) 2018, femoro - femoral bypass was performed for the blood flow to the left leg.Also, a bare metal stent was implanted from aorta to the right common iliac artery.

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.Corrected data: method code 2.Results code 1.Conclusions code 1.

• 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: 7752990
• MDR Text Key: 116120287
• Report Number: 2017233-2018-00484
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2021
• Device Catalogue Number: BXA075901J
• Device Lot Number: 18240683
• 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): Required Intervention