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

Catalog Number	BXA062901A
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.Engineering evaluation is currently being conducted on the returned device components.Endoprosthesis remains implanted.Instructions for use (directions for use, section g) states, after deploying the endoprosthesis, slowly deflate the balloon manually using the inflation device to ensure proper balloon rewrap / refold.Allow adequate time for the balloon to fully deflate prior to removal.Observe fluoroscopically that the balloon is fully deflated prior to removal.Maintaining proper sheath or guide catheter support, very slowly withdraw the balloon.Observe under fluoroscopy to ensure that the balloon disengages from the stent.If resistance is encountered upon attempted removal, do not force removal, use fluoroscopy and conventional techniques to determine and remedy the cause of resistance before proceeding.The balloon needs to be fully deflated to ensure it disengages fully from the endoprosthesis.While maintaining negative pressure in the balloon and the guidewire position across the treated lesion, carefully remove the delivery catheter from the body through the sheath or guide catheter.Moderate resistance may be felt when the balloon is withdrawn through the introducer sheath.Note: if, during catheter removal, the balloon catches on the leading edge of the introducer sheath, a slight ¿back and forth¿ motion of the catheter may aid in release.If needed, the delivery catheter and the sheath or guide catheter may be removed together as a unit.Excessive or abrupt force during catheter removal may damage the delivery catheter, or introducer sheath.
Event or Problem Description
The following was reported to gore: during an abdominal aorta aneurysm procedure, access was made from the femoral artery.An endologix ovation device was placed in the main body, and a gore® viabahn® vbx balloon expandable endoprosthesis was deployed to preserve perfusion in a slightly stenosed renal artery.As reported, three additional devices were deployed and delivery catheters were removed from same femoral access with no issues.After deployment of the vbx device, the deflated balloon and catheter were being removed when the balloon became stuck and could not be withdrawn through the 7fr cook sheath.A cut down was done at the brachial artery and the vbx balloon and catheter were removed from the arm.The patient tolerated the procedure and was reported to be recovering well.
Additional Manufacturer Narrative
B5 - event description was updated.H6 - code 213: the returned device was identified to be 6 x 29 x 800 mm configuration.The endoprosthesis had been deployed but the delivery catheter remained in an introducer sheath.The sheath was not evaluated as it is not a gore product.The catheter shaft was able to be manipulated within the introducer sheath.The cover material was separated and detached from the balloon.The catheter was kinked at the hub joint.Based on the device examination performed and the information available, no manufacturing anomalies were identified to which the event could be definitively attributed.
Event or Problem Description
Additional information from the physician was obtained.The balloon catheter may have encountered an ovation aaa device strut, causing damage to the vbx device during withdrawal.The gore® viabahn® vbx balloon expandable endoprosthesis (lot #18674112) that was advanced from the arm through the 7fr cook sheath was the only one that encountered issues during the withdrawal of delivery catheter.The four implanted vbx devices had different entry points.They were not all advanced from the same entry points as stated in original description.

• 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: 8651792
• Report Number: 2017233-2019-00378
• Device Sequence Number: 13996496
• Product Code: NIO
• UDI-Device Identifier: 00733132637461
• UDI-Public: 00733132637461
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2021
• Device Catalogue Number: BXA062901A
• Device Lot Number: 18674112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 78