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

Model Number	BXAL083902A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.
Event or Problem Description
The following was reported to gore: the doctor advanced the sheath up and over.The 8x39 gore® viabahn® vbx balloon expandable endoprosthesis was advanced through the sheath with difficulty.When the device stopped advancing the doctor decided to remove the device.The doctor reported that he pulled the sheath back and attempted to pull the device back into the sheath.The device dislodged from the catheter on the ipsilateral side but was still on the wire.The doctor ran a 4mm balloon into the device and deployed it in the ipsilateral iliac.There was no harm to the patient.
Additional Manufacturer Narrative
Corrected data: h6.Method code 2.H6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: examination of the returned device revealed the following: the gore® viabahn® vbx balloon expandable delivery system was returned without the endoprosthesis and did not appear to have been inflated.The device displayed catheter damage at 91 cm from the proximal end of the delivery system.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use warnings section state the following: 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.
Additional Manufacturer Narrative
Corrected data: b5.Describe event or problem.H6.Method code 1.
Event or Problem Description
The following was reported to gore: the procedure required an additional gore® viabahn® vbx balloon expandable endoprosthesis (vbx) to treat the contra lateral iliac.The doctor advanced the sheath up and over with a tight aortic bifurcation.The 8x39 vbx was advanced through the 8fr terumo sheath with difficulty.When the device stopped advancing the doctor decided to remove the device.The doctor reported that he pulled the sheath back and attempted to pull the device back into the sheath.The device dislodged from the catheter on the ipsilateral side but was still on the wire.The doctor ran a 4mm balloon into the device and deployed it in the ipsilateral iliac.There was no harm to the patient.

• 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: 9540124
• Report Number: 2017233-2020-00003
• Device Sequence Number: 2460990
• Product Code: NIO
• UDI-Device Identifier: 00733132637829
• UDI-Public: 00733132637829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: BXAL083902A
• Device Catalogue Number: BXAL083902A
• Device Lot Number: 21359840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• 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: 01/02/2020
• Supplement Report FDA Received Date: 01/30/2020; 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR