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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL Back to Search Results
Catalog Number BXA065902F
Device Problem Complete Blockage (1094)
Patient Problem Occlusion (1984)
Event Date 10/06/2019
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
 
Event Description
On (b)(6) 2014, this patient underwent endovascular treatment for an aortic aneurysm of unknown maximum diameter and involved visceral branch vessels.The patient is enrolled in the aaa 13-02 tambe ide study.It was reported that the procedure included implant of gore® viabahn® vbx balloon expandable endoprostheses in the renal arteries.On (b)(6) 2019 both renal arteries were occluded.The event is ongoing.
 
Event Description
On (b)(6) 2014, this patient underwent endovascular treatment for an aortic aneurysm of unknown maximum diameter and involved visceral branch vessels.The patient is enrolled in the aaa 13-02 tambe ide study.It was reported that the procedure included implant of gore® viabahn® vbx balloon expandable endoprostheses in the renal arteries.On (b)(6) 2019 both renal arteries were occluded.On (b)(6) 2019 a thrombectomy was performed on each side and the right renal artery stents were relined with a non-gore bare metal stent.This report covers the occlusion of the right renal artery occlusion.
 
Manufacturer Narrative
D.11.The second device utilized in the right renal was bxa065902f, serial number: (b)(6), udi: (b)(4).As it is not known if one or both of the devices were occluded, both were investigated.
 
Manufacturer Narrative
H.6.Method and results code 2 added.Note the left renal artery occlusion is being reported under complaint (b)(4), report # 2017233-2020-01161.
 
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Brand Name
GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
Type of Device
ILIAC COVERED STENT, ARTERIAL
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10449808
MDR Text Key204247624
Report Number2017233-2020-01157
Device Sequence Number1
Product Code PRL
Combination Product (y/n)Y
PMA/PMN Number
P160021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/17/2016
Device Catalogue NumberBXA065902F
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
Patient Weight63
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