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

Model Number	BXA085901A
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	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.Reference medwatch #2017233-2020-00439 for the 1st device.
Event or Problem Description
It was reported to gore on (b)(6) 2020 a procedure was being performed using a gore® viabahn® vbx balloon expandable endoprosthesis.The physician reported the patient had tortuous anatomy which he believes caused the stent to fall off the balloon.He then tried another vbx of the same size and that stent came off the balloon as well.Patient disposition is unknown at this time.This medwatch report is for the 2nd reported device.
Additional Manufacturer Narrative
Additional manufacturer narrative: 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 that would contribute to dislodgement.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
Additional Manufacturer Narrative
Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #21046410.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10247886
• Report Number: 2017233-2020-00465
• Device Sequence Number: 19549451
• Product Code: PRL
• UDI-Device Identifier: 00733132637324
• UDI-Public: 00733132637324
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2020

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: 07/09/2022
• Device Model Number: BXA085901A
• Device Catalogue Number: BXA085901A
• Device Lot Number: 21046410
• 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; Not provided
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 07/27/2020; 07/27/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other