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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Catalog Number PAH101002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2015
Event Type  Injury  
Manufacturer Narrative
The following literature article was reviewed: ¿p-186 early and long term results of viabahn endograft for treatment of supra aortic trunks aneurysm¿.Paola wiesel, et al.European journal of vascular and endovascular surgery; volume 58, issue 6, supplement 2, december 1, 2019, page e513, https://doi.Org/10.1016/j.Ejvs.2019.06.1197.Date of event: the date of event was requested but remains unknown.It was reported that the viabahn device occluded four years after implant.Therefore, (b)(6) 2015, was selected as a best estimate.(b)(4): requests were sent to the author to provide additional information to for example procedure, device serial number, event, aetiology, symptoms and patient data.The device serial number could not be obtained.(b)(4): the device remains implanted.Therefore no engineering evaluation of the device could not be performed.(b)(4): the device serial number could not be obtained.Therefore the manufacturing records could not be reviewed.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
The following literature article was reviewed: ¿p-186 early and long term results of viabahn endograft for treatment of supra aortic trunks aneurysm¿.Paola wiesel, et al.European journal of vascular and endovascular surgery; volume 58, issue 6, supplement 2, december 1, 2019, page e513.Https://doi.Org/10.1016/j.Ejvs.2019.06.1197.The goal of this retrospective study was to evaluate early and long term results of gore® viabahn® endoprosthesis with propaten bioactive surface in the treatment of supra aortic trunk (sat) aneurysm.From 2009 to 2017 three female and ten male patients were treated for sat: 8 subclavian artery, 2 internal carotid artery, 2 common carotid artery, 1 vertebral artery.Aetiology was posttraumatic in four cases, vasculitis in two cases and atherosclerosis in seven cases.Four patients experienced compression symptoms, six patients were treated in an emergency setting (3 for pain and 3 for rupture), while three patients were asymptomatic.All the subclavian artery aneurysms were treated through a surgical exposure of the ipsilateral brachial artery, while in the remaining patients a percutaneous femoral approach was performed.Technical success was 100% and no early complications were recorded.Mean follow up was 3.5 years (1-8 years).Primary patency was 100%.Within the literature the following case was reported: one patient had an asymptomatic occlusion of the viabahn device implanted in the subclavian artery after four years.Requests were sent the author to provide additional information.The author provided the following additional information: on (b)(6) 2011, the patient underwent endovascular treatment of an asymptomatic aneurysm of the subclavian artery with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn device, pah101002).The aneurysm was diagnosed by chance during a follow-up examination of the aortic arch replacement, which was performed because of an aneurysm a few years earlier.The aetiology of the of the subclavian artery aneurysm was atherosclerosis as it was for the aortic arch aneurysm previously.Four years after the subclavian artery aneurysm repair an occlusion of the viabahn device implanted in the subclavian artery was diagnosed.The author stated, that the occlusion was totally asymptomatic at this time and is still asymptomatic today.Therefore they decided not to treat the occlusion or perform any type of reintervention.They have no suspects what caused the occlusion and what was the root cause.
 
Manufacturer Narrative
Section d: corrected product code.Section g: corrected pma/510(k)number.
 
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Brand Name
GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10494371
MDR Text Key212139618
Report Number2017233-2020-01223
Device Sequence Number1
Product Code NIP
Combination Product (y/n)Y
PMA/PMN Number
P130006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPAH101002
Was Device Available for Evaluation? No
Date Manufacturer Received10/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age46 YR
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