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

Catalog Number BXA075901J

Device Problems Complete Blockage (1094); Collapse (1099)

Patient Problem Stenosis (2263)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Event Description

Following was reported to gore: in (b)(6), 2020, a patient underwent endovascular treatment of in-stent restenosis of the left common iliac artery using gore® viabahn® vbx balloon expandable endoprosthesis(vbx).The procedure was completed without any issues.Date unknown, it was confirmed that the vbx was compressed and was occluded by thrombosis.On (b)(6) 2020, reintervention placing two bare metal stents was performed.The intraoperative imaging confirmed blood flow, and the procedure was completed.The patient tolerated the procedure.Note: the physician reported that the vbx might have been compressed by some kind of external pressure.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #21341189.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Corrected data: d2.- common device name.

• 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: 10252701
• MDR Text Key: 198177240
• Report Number: 2017233-2020-00466
• Device Sequence Number: 1
• Product Code: PRL
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Catalogue Number: BXA075901J
• Device Lot Number: 21341189
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/16/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR