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

Model Number BXA085901A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2020

Event Type  malfunction  

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 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.

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.

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
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10247886
• MDR Text Key: 199052550
• Report Number: 2017233-2020-00465
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637324
• UDI-Public: 00733132637324
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/27/2020; 07/27/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other