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

Catalog Number	BXA117902A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device: bxa115902a udi: (b)(4) reported separately.A review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient with a previously implanted medtronics device was undergoing treatment of a thoraco-abdominal aortic dissection with additional non-gore aortic components.(tapered valiant and endologics devices).The sma and celiac arteries were treated in snorkel technique with gore® viabahn® vbx balloon expandable endoprostheses.Following placement of the taperd valiant device, the vbx devices were advanced over.035" boston scientific/amplatz superstiff wires through an 8fr.Terumo destination sheath, from right brachial access, to the sma and celiac arteries.Then the endologics device was advanced and deployed.Next the vbx devices were balloon expanded.After this, it was noticed both balloon catheters broke, in the same region, approximately 5cm from the hub of the catheter.The catheter segment from the sma treatment site was able to be removed with the sheath over the wire, however the catheter segment from the celiac treatment site became stuck on the wire so the sheath, wire and catheter segment were all removed.Sheath access was re-gained and the procedure ensued.There was no injury to the patient.
Additional Manufacturer Narrative
Results code 2: 213: the engineering analysis stated the following: the device was identified as an 11 x 79 x 1350 (mm) configuration, which matches the event description.Device was received deployed and with the catheter shaft and hub separate from each other.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: 7716301
• Report Number: 2017233-2018-00431
• Device Sequence Number: 1065656
• Product Code: NIO
• UDI-Device Identifier: 00733132637768
• UDI-Public: 00733132637768
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/24/2018

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: 05/09/2021
• Device Catalogue Number: BXA117902A
• Device Lot Number: 18212828
• Was Device Available for Evaluation?: No
• 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: 07/24/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR