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

Catalog Number	BXA115901A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) 2019 a patient was undergoing treatment of unknown type/location with a gore® viabahn® vbx balloon expandable endoprosthesis.Reportedly the device was advanced just past the sheath when the delivery catheter broke.
Additional Manufacturer Narrative
H.6.Conclusion code 1: updated h.6.Results code 2: 213: the engineering evaluation stated the following: the 11 x 59 device had not been deployed.The cover material beyond the stent is compliant on both ends.The 11 x 59 device hub was separated from the catheter.Necking on the catheter occurred from 9.25-10.25 cm, 17.5-20 cm, and 76-87.5cm ¿ the distance measured to the proximal end of the balloon.Visible catheter damage was displayed from 57.5-58 cm and 68.5-70.5 cm.Based on the device examinations performed, no manufacturing anomalies were identified to which the event could be definitively attributed.A second device in this event is being reported separately under mfr report # 2017233-2019-00355.
Event or Problem Description
On (b)(6) 2019 a patient was undergoing treatment of a stenotic occlusion of unknown location with a gore® viabahn® vbx balloon expandable endoprosthesis.Reportedly the device was advanced just past the sheath when the delivery catheter broke.
Additional Manufacturer Narrative
B.5.Updated.

• 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: 8618162
• Report Number: 2017233-2019-00356
• Device Sequence Number: 2074615
• Product Code: NIO
• UDI-Device Identifier: 00733132637737
• UDI-Public: 00733132637737
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2019

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: 05/24/2021
• Device Catalogue Number: BXA115901A
• Device Lot Number: 18315843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• 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: 05/16/2019
• Supplement Report FDA Received Date: 06/05/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR