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

Catalog Number	BXA062902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an abdominal aortic aneurysm with a cook fenestrated aaa device system.Following implantation of the main body of the cook device, the renal arteries were cannulated.A 6mm x 40mm ev3 everflex stent was placed in the left renal artery.An attempt was made to advance a 7fr sheath into the right renal artery for delivery of a 6mm x 29mm gore® viabahn® vbx balloon expandable endoprosthesis.The sheath was advanced to the opening of the right renal artery, since it would not go inside the artery.The vbx device was pushed and pulled in attempt to cannulate the artery.The stent then dislodged from the balloon delivery catheter.This was reportedly likely due to pushing too hard as well as the device possibly catching on the previously implanted device and/or catching on some calcium at the origin of the renal artery.As well, the sheath couldn¿t be advanced as far as desired to protect the device.The vbx was not able to be recaptured, so it was left in the patient, within the aneurysm where it was successfully covered by the cook main body devices.Eventually a 12fr gore® dryseal sheath was advanced to the right renal artery and a 6mm x 19mm vbx device was successfully implanted distally.A 7mm x 19mm vbx device proximally, bridging the everflex stent in the left renal to the cook main body.The right renal and superior mesenteric vbx treatments were successful.There was a type i endoleak noted at the end of the procedure coming from behind or under the cook device, unrelated to the vbx¿s which was thought to resolve on its own.The patient is being monitored.
Additional Manufacturer Narrative
Results code 2: 213: the engineering evaluation stated the following: the device was identified to be a 6 x 29 x 1350 mm configuration, which matches the event description.The received device contained only the delivery system.The delivery system was observed to be un-deployed which matches the event description.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 7988149
• Report Number: 2017233-2018-00632
• Device Sequence Number: 1105385
• Product Code: NIO
• UDI-Device Identifier: 00733132637478
• UDI-Public: 00733132637478
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 06/09/2021
• Device Catalogue Number: BXA062902A
• Device Lot Number: 18371145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• 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: 10/20/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR