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

Catalog Number BXA075901J

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

The devices remain implanted in the patient, therefore they are not available for direct product analysis.Reference medwatch #2017233-2020-00441 for other device for this event.Reference medwatch #2017233-2020-00436 & 2017233-2020-00435 for original event dated (b)(6) 2020.

Event Description

Following was reported to gore.On (b)(6) 2020, a patient underwent endovascular treatment of occlusion of the aorta and bilateral iliac arteries using gore® viabahn® vbx balloon expandable endoprosthesis(vbx).It was reported that the iliac arteries were highly calcified, and that the two vbx were placed by kissing stent technique.It was not reported which vbx were placed at which side.The procedure was completed without any issue.In mid (b)(6) 2020, the patient complained pain on the left leg, and she reported that the pain had recurred approximately two weeks after the initial procedure.An examination imaging revealed the vbx at the left common iliac artery was compressed and almost occluded.On (b)(6) 2020, a reintervention was performed.The vbx was relined with additional two stentgraft.The patient tolerated the procedure.(reported under event# (b)(4)).On june 11, 2020, it was reported that the two vbxs placed on (b)(6) were compressed and almost occluded.A femoral- femoral bypass is planned.

Manufacturer Narrative

Corrected data: d2: common device name.

Manufacturer Narrative

Additional manufacturer narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #21065971.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: h6.- results code 1.H6.- conclusions code 1.Additional 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.

• 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: 10165757
• MDR Text Key: 195542963
• Report Number: 2017233-2020-00442
• 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,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: BXA075901J
• Device Lot Number: 21065971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other