2008
DOI: 10.1002/ccd.21435
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Common femoral artery stenosis after deployment of vascular clip closure device

Abstract: We describe a case of symptomatic common femoral artery stenosis following use of a vascular clip closure device (StarClose). Operative repair was performed, with removal of the clip device and subsequent vein patch angioplasty.

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Cited by 6 publications
(4 citation statements)
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“…The US Food and Drug Administration MAUDE (Manufacturer and User Facility Device Experience) database http:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/ search.cfm on VCDs cites 22 deaths in 2007, including 3 related to complications of vascular obstruction (though none of these were after StarClose use), the issue in this month's report by Osborn et al [6]. It should be noted that MAUDE is highly flawed, some of the complications may not have had a causal relationship with VCDs, and the reporting is grossly incompleteboth in terms of numbers actually reported and the quality of the reporting.…”
mentioning
confidence: 90%
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“…The US Food and Drug Administration MAUDE (Manufacturer and User Facility Device Experience) database http:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/ search.cfm on VCDs cites 22 deaths in 2007, including 3 related to complications of vascular obstruction (though none of these were after StarClose use), the issue in this month's report by Osborn et al [6]. It should be noted that MAUDE is highly flawed, some of the complications may not have had a causal relationship with VCDs, and the reporting is grossly incompleteboth in terms of numbers actually reported and the quality of the reporting.…”
mentioning
confidence: 90%
“…The most common and egregious error is failure to perform a routine angiogram prior to device deployment. However, in the case report by Osborn et al [6], their femoral angiogram is perfect in my estimation. The right anterior oblique view beautifully shows the puncture to be above the femoral bifurcation and well below the inferior epigastric artery; furthermore the puncture site is at the ideal location below the centerline of the femoral head.…”
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confidence: 90%
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“…Acute limb ischemia (ALI) or new‐onset claudication (CI) after PIs as a result of complicated vascular access and/or closure are infrequent conditions [6–9]. However, recently ALI and/or CI were increasingly reported after use of different vascular closure devices (VCD), such as Angio‐Seal (St. Jude Medical, St. Paul, MN) [6–14], Starclose (Abbott Vascular Devices, Redwood City, CA) [15–18], Perclose (Abbott Vascular Devices, Redwood City, CA) [19, 20], and earlier with the Duett device (Vascular Solutions, Minneapolis, MN) [21]. Up to date, only case reports and series including small numbers of patients are published: numbers of patients involved, associated VCD, and resulting treatment are summarized in Table I.…”
Section: Introductionmentioning
confidence: 99%