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

Model Number	BXA083902A
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	11/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was undergoing vascular treatment of both common iliac arteries with gore® viabahn® vbx balloon expandable endoprostheses.The intent was to position the devices in kissing technique.The anatomywas described as "minimally tortuous".One of the vbx devices (8mm x 39mm) was attempted to be advanced to the target location.As it was being pushed through the occluded area, which had not been pre-dilated, it was realized the stent was the wrong size.This device was attempted to be removed, but when it was being pulled back, the stent came off the balloon catheter.This stent was then expanded with another balloon catheter to dilate it.A longer (8mm x 59mm) gore® viabahn® vbx balloon expandable endoprosthesis was then advanced through the first stent and deployed to complete the length of the treatment.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional manufacturer narrative: corrected data: h6 - method code 2.H6 - results code 1.H6 - conclusion code 1.The referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.The device history file was reviewed and no anomalies were identified.Crush force is controlled through machine maintenance and calibration.Machine history files were reviewed and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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: 9370687
• Report Number: 2017233-2019-01184
• Device Sequence Number: 19382510
• Product Code: NIO
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 02/04/2020

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: 08/06/2022
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Device Lot Number: 21205391
• 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; Not provided
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/16/2020; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1