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

Catalog Number	BXAL085901A
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 broke after it was deployed.The delivery system was attempted to be pulled out of the patient.
Additional Manufacturer Narrative
H.6.Conclusion code 1: updated.H.6.Results code 2: 213: the engineering evaluation stated the following: the 8l x 59 stent had been deployed; however, the catheter was split into 3 pieces with the middle of those pieces stuck on the guidewire.The section attached to the hub had catheter damage from 18.5-19.5 cm and necking from 25cm until the break at 37 cm (as measured from the hub).The middle portion on the guidewire was 37 cm long and displayed necking across that whole length.The third section with the balloon had necking that extended 21 cm from the break.Based on the device examinations performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
Event or Problem Description
On (b)(6) 2019 a patient was undergoing treatment of a stenotic occlusion of unknown anatomical location, with a gore® viabahn® vbx balloon expandable endoprosthesis.Following device deployment the delivery catheter broke upon removal from the patient.
Additional Manufacturer Narrative
B.5.Updated.
Event or Problem Description
On (b)(6) 2019 a patient was undergoing treatment of unknown type/location with a gore® viabahn® vbx balloon expandable endoprosthesis.Reportedly the device broke after it was deployed.The delivery system was broken upon removal from the patient.
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: 8618142
• Report Number: 2017233-2019-00355
• Device Sequence Number: 16660425
• Product Code: NIO
• UDI-Device Identifier: 00733132637836
• UDI-Public: 00733132637836
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 12/11/2021
• Device Catalogue Number: BXAL085901A
• Device Lot Number: 20085136
• 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; Not provided
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/05/2019; 07/04/2019; 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