This literature article report is a retrospective study which reviewed the cases in which complications occurred during below-the-knee (btk) endovascular treatments that were performed at our hospital from 2005 to 2014.Ten cases have been described herein.All the patients had diabetes and non-healing wounds on their feet and/or rest pain in their foot or leg, and therefore, endovascular treatment was performed for the btk arteries of the affected lower extremity.The complications that occurred during the procedure were classified into six categories¿vascular spasm, flow limiting dissection, perforation, broken guidewire, distal thromboembolism, and unusual puncture site bleeding.Each complication has its own solutions and management.Endovascular procedures were performed under local anesthesia by interventional radiologists in an interventional radiology suite.The common femoral artery (cfa) was punctured using a non-medtronic micropuncture set under ultrasound guidance and sheath insertion was performed.Angiography using non-ionic contrast medium or carbon dioxide (for patients with poor renal function) and digital subtraction angiography were performed through the sheath to evaluate entire lower extremity arteries.In addition to those with only btk artery lesions, some patients had lesions in the ilio-femoropopliteal arteries.Although all affected arteries were treated in these patients, this report only investigated the treatment of btk arteries.The steno-occlusive lesions of the btk arteries were crossed using dedicated 0.018 or 0.014 inch non-medtronic guidewires.A trailblazer support catheter and a non-medtronic guiding sheath were used to provide better support.An antegrade approach was initially attempted by puncturing the cfa.In cases with restricted or no access through the cfa, we attempted retrograde access via the distal btk vessels.In some cases, a pedal or plantar artery approach was also attempted.The btk lesion was passed using these approaches and balloon angioplasty was then performed.During the procedure, complications were detected with a follow-up angiogram and appropriately managed.At the end of the procedure, we confirmed the establishment of bloodflow in at least one btk artery to ensure perfusion to the patient¿s foot.Case 10: the patient presented with primary symptoms of rest pain and coldness in the right foot.The right distal posterior tibial artery (pta) showed relatively good flow, but occlusion was present at the origin of the pta without a proximal stump.A retrograde puncture was performed using a non- micropuncture set on the distal pta at the ankle level.Angioplasty was successfully performed after passage of the guidewire through the entire pta.However, contrast leakage was observed on follow-up angiography at the anterior aspect of the ankle, presumably due to a retrograde puncture site bleeding.Balloon tamponade was performed using a 2.5 mm x 22 cm balloon for 15 minutes, but a small amount of bleeding persisted.After manual external compression of the patient¿s ankle for 10 minutes, the bleeding stopped completely.These finding suggests that the bleeding was not from the punctured vessel itself, but from a small branch along the pathway of the puncture route.
|
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.
|