|
Journal title percutaneous treatment of delayed post-atherectomy superficial femoral artery pseudoaneurysm j invasive cardiol 2012;24(10):e212¿e214.B3 date of publication.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Patient had been on appropriate medical management including an exercise regimen for approximately 9 months with no improvement in symptoms.He underwent a peripheral angiogram that showed chronic total occlusion (cto) of the right and sfa (figure 1).Since the left sfa was more symptomatic, we proceeded with a left sfa intervention.After anticoagulation with bivalirudin, the lesion was crossed with a combination of a terumo glidewire (terumo corporation) and a confianza pro wire (abbott vascular) with trailblazer catheter (ev3 endovascular) support.After confirmation of the distal end being in the true lumen by contrast injection through the trailblazer catheter, atherectomy was performed with a turbohawk lx-c device (ev3) followed by balloon angioplasty with a 5.0 mm x 120 mm evercross balloon (ev3).There were no immediate complications and successful reduction of stenosis to <(> <<)>10% (figure 2).The patient was discharged home the following day without complications.A week later, the patient presented to the hospital with acute onset and worsening pain in his left thigh over the last 3 days and it was associated with ecchymosis and swelling.A ct angiography was performed and showed a fusiform aneurysm 4 cm x 27 mm diameter in the proximal third of the left sfa (figure 3).Repeat angiogram confirmed the findings (figure 4).Over a 0.014 ironman wire (abbott vascular), a 6.0 mm x 10 cm viabahn endoprosthesis (w.L.Gore <(>&<)> associates) was deployed and postdilated by a 6.0 mm x 40 cm balloon at nominal pressure at 9 atm.There was a persistent leak at the distal part of the aneurysm, so another 7.0 mm x 5 cm viabahn stent was placed and again postdilated by a 6.0 mm x 40 mm compliant balloon at nominal pressure.Final angiogram showed successful exclusion of the pseudoaneurysm (figure 5) and the patient tolerated the procedure well with no complications.One week later, the patient again presented to the hospital for worsening pain in his left thigh.Repeat ct angiography showed patent stent grafts with resolution of pseudoaneurysm.The patient¿s symptoms improved by using a lidocaine patch and ibuprofen with no new symptoms in the 6 months follow-up.Discussion.Silverhawk atherectomy (ev3) is an effective treatment in peripheral vascular disease with plaque excision and a gradual and progressive increase in lumen size.As the device is advanced through the lesion, plaque is excised and packed in the nosecone.Different planes of excision are achieved by rotation of the device.It can be used as stand-alone therapy or with balloon angioplasty/stenting.There are potential complications with atherectomy such as distal embolization, no flow, and ischemia.1 in the treating peripherals with silverhawk: outcomes collection (talon) registry,1 perforation rate was 0.8%, = grade c dissection 0.8%; 30-day occlusion and thrombosis rate was 0.1%.Directional atherectomy in coronary arteries has been associated with perforations4 and aneurysm formation in up to 10% of patients.5 however, after atherectomy there are only few reported cases of popliteal artery and sfa pseudoaneurysm formation in the literature.2 ,6 these interventions were done for complex plaque in both vessels without cto and their presentations are not as dramatic as our patient.Our patient had acute onset of pain associated with ecchymosis and swelling after being ambulatory for several days, suggestive of late rupture of the sfa with pseudoaneursym formation.Atherectomy samples from peripheral arteries had 21% medial and 1% adventitial component of the arterial wall, which is much lower compared to coronary samples at 67% and 27%, respectively.7 having a cto and wire bias might have resulted in deeper cuts in our patient with weakening of the arterial wall and subsequent rupture as a result of increased mechanical stress associated with ambulation and arterial pressure.A viabahn covered stent was used to successfully treat the pseudoaneurysm in our patient.The viabahn endoprosthesis is constructed of nitinol and expanded polytetrafluoroethylene (eptfe) lining and has a proprietary heparin bioactive surface.It has been shown in observational studies and randomized trials to be an effective and safe treatment strategy compared to bare self-expanding stents and surgical prosthetic bypass grafts.8 a randomized prospective study showed comparable 1-year patency self-expanding eptfe/nitinol stent graft vs surgical femoral-to-above knee popliteal artery bypass with synthetic graft material (73.4% vs 74.2%) in treating sfa occlusive disease.9 when viabahn stent grafts were placed into 87 limbs in 76 patients for the treatment of atherosclerotic occlusive disease of the femoropopliteal obstruction with a mean lesion length of 14.2 cm, primary patency rates were 76% at 1 year and 55% at 4 years.Primary patency was independent of lesion length and type but dependent on device diameter (p=.001) with a 4-year, 82% patency rate in devices of at least 7 mm.10 the viabahn stent has been used for treatment of pseudoaneurysms in the popliteal artery.In a single center study, 18 patients underwent endothelialization of popliteal pseudoaneurysms with the viabahn endograft with patency and exclusion of aneurysm rate of 86% in 6 months.11 it has also been successfully used in to treat iatrogenic post-pacemaker axillary artery pseudoaneurysms12 and carotid artery pseudoaneurysms after carotid surgery or radical neck dissection.13-15 in animal studies, complete endothelialization inside eptfe nitinol stents may take up to 6 months.16 re-occlusions mostly occurred in the first year after hemobahn/viabahn endoprosthesis placement and 21% were in the first 30 days,17 which emphasizes the importance of antiplatelet therapy in these patients.Progression of other sfa lesions outside the hemobahn/viabahn endoprosthesis also increases the possibility of re-occlusion.17 due to this, routine abi/duplex ultrasound screening should be considered in follow-up.Conclusion as seen in our case, delayed perforations at the silverhawk atherectomy site can occur after ambulation with associated symptoms of ecchymosis, pain, and swelling.Patients with such symptoms will require prompt evaluation of the atherectomy site.The viabahn stent can be used as a treatment option for treatment of pseudoaneurysms in the sfa.
|
