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Event description continued: doppler ultrasonography showed flow acceleration at the proximal lsa (300 cm/s;).A contrast-enhanced computed tomography angiography (cta) showed a severe stenosis in the proximal lsa (length: 30 mm; reference diameter 10 mm distal to the stenosis: 9 mm).Patient¿s symptoms were attributed to hypoperfusion of left arm and low coronary flow through the lima bypass.The patient was scheduled for percutaneous intervention on the lsa.The procedure was carried out from a right femoral access.A 70-mmhg gradient was noticed across the stenosis.After balloon dilatation at 8 atm with a 6x20-mm powerflex pro balloon (cordis corp., miami lakes, fl), a self-expandable 10x40 mm smart (cordis corp.) bare-metal stent (bms) was implanted in the proximal lsa, with little ostial protrusion (2-3 mm) in the aorta.A 15-mmhg residual gradient was documented and postdilatation (10 atm) was performed with a 10x40-mm powerflex pro balloon.At this point, a dissection was noticed at the distal edge of the stent, which extended distally involving the ostium of the left vertebral artery.The dissection was immediately sealed with a second overlapping 8x30 mm smart stent (, in order to prevent extension into the vertebral circulation.To avoid stent malapposition at the overlap region, a final balloon postdilatation (10 atm) was performed in the proximal lsa with a 10x40- mm powerflex pro balloon.Final angiography showed an optimal result, without residual pressure gradient, and normal flow in the left vertebral artery.The patient remained asymptomatic throughout the procedure.In the following hours the patient developed intense abdominal pain refractory to conventional analgesia, accompanied by hematochezia.Physical exam and vital signs were normal.Laboratory test were remarkable for hyperlactatemia (13 mmol/l; normal values <2.2 mmol/l) with normal renal function.Mesenteric ischemia was suspected and a thoracoabdominal cta was performed.An aortic dissection extending from the origin of the lsa to the right common iliac artery was diagnosed.Detailed analysis clearly showed the relationship between the proximal edge of the stent and the origin of the dissection, which involved distally the sma.Conversely, the dissection did not extend into the ostium of celiac trunk, which was nevertheless compressed by the dissection flap.The right renal artery aroused from the true lumen while the left renal artery originated from the false lumen.Small bowel wall edema confirmed the diagnosis of mesenteric ischemia.There was also evidence of left kidney hypoperfusion, although this was mitigated by the presence of a fenestration between the two lumens in correspondence with the origin of the left renal artery.In light of the life-threatening mesenteric ischemia caused by aortic dissection, urgent percutaneous intervention on the affected splanchnic branches was performed.Under deep sedation and from a left femoral artery access (in order to assure access to the true lumen), a 6-french judkins right guiding catheter (cordis corp.) was positioned through a 45-cm sheath into the ostium of the celiac trunk.A balloon-expandable 7x18-mm racer rx bms (medtronic, (b)(4)) was placed at the ostial-proximal level with optimal result.Subsequently, we performed angioplasty of the ostial sma.A 6x12-mm racer rx stent was used, but due to distal migration during inflation, an overlapping 7x12-mm racer rx stent was implanted proximally with optimal result.Mesenteric ischemia rapidly subsided, and patient¿s hospital course was uncomplicated thereafter.Dual antiplatelet therapy (aspirin 80 mg daily lifelong and clopidogrel 75 mg daily for 12 months) was prescribed.One month later, the patient was free from angina or left arm claudication.However, a follow-up cta showed progressive dilatation of the descending thoracic aorta (maximum diameter: 40 mm) and thoracic endovascular aorta repair (tevar) was planned to prevent further dilatation and minimize the risk ofaortic rupture.Since coverage of the lsa was anticipated and in order to maintain blood supply to the left arm, a left carotid to lsa bypass was performed two days before tevar.Under general anesthesia, with transesophageal echocardiography guidance and through a left femoral access, tevar was performed successfully.A 6x202-mm zenith tx2 self-expandable endoprosthesis (cook medical inc.(b)(4)) was positioned slightly proximal to the lsa ostium and extending distally to the descending thoracic aorta.During the same intervention, proximal lsa occlusion was performed in order to prevent a type 2 endoleak caused by retrograde flow from the carotid bypass, which could eventually cause detachment of the endoprosthesis and proximal extension of the dissection to the aortic arch and ascending aorta (6, 7).Four 15- mm-by-40-cm interlock-35 detachable coils (boston scientific corp., (b)(4)) were successfully deployed through a left radial access.The patient was then discharged after an uncomplicated hospital course.At two month follow-up he was asymptomatic.Follow-up cta showed complete exclusion of the aortic aneurysm and total occlusion of the proximal lsa, with distal flow through the carotid-subclavian bypass.This article was found during a recent clinical evaluation review/literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The citation is as follows: by millan et al iatrogenic subclavian artery and aortic dissection with mesenteric ischemia following subclavian artery angioplasty: endovascular management, catheterization and cardiovascular interventions (2015) 1-16.Please note that the exact catalog and lot numbers are not available.Although the size of the device was provided the exact catalog number is not known.Concomitant products: dual antiplatelet therapy (aspirin 80 mg daily lifelong and clopidogrel 75 mg daily for 12 months) was prescribed.As noted in the publication by millan et al iatrogenic subclavian artery and aortic dissection with mesenteric ischemia following subclavian artery angioplasty: endovascular management, catheterization and cardiovascular interventions (2015) 1-16; a 61-year-old male with past history of hypertension and hypercholesterolemia was admitted at our institution with non st-elevation myocardial infarction.Coronary angiography showed three-vessel disease (syntax score: 23).Left ventricular ejection fraction was 25%.After heart team discussion, cabg was performed: left internal mammary artery (lima) to the left anterior descending artery, and three saphenous venous grafts to the first diagonal, first marginal and posterior descending artery.The patient was discharged after an uneventful postoperative course.Three weeks later, the patient consulted for dyspnea and angina on exertion.He also complained of left arm claudication and paresthesias.Physical exam was remarkable for a cold left arm, with weak left radial pulse.A diminished systolic blood pressure in left arm was noticed (40 mmhg difference between arms).Lsa stenosis with subclavian steal phenomenon was suspected.Doppler ultrasonography showed flow acceleration at the proximal lsa (300 cm/s;).A contrast-enhanced computed tomography angiography (cta) showed a severe stenosis in the proximal lsa (length: 30 mm; reference diameter 10 mm distal to the stenosis: 9 mm).Patient¿s symptoms were attributed to hypoperfusion of left arm and low coronary flow through the lima bypass.The patient was scheduled for percutaneous intervention on the lsa.The procedure was carried out from a right femoral access.A 70-mmhg gradient was noticed across the stenosis.After balloon dilatation at 8 atm with a 6x20-mm powerflex pro balloon (cordis corp., (b)(4)), a self-expandable 10x40 mm smart (cordis corp.) bare-metal stent (bms) was implanted in the proximal lsa, with little ostial protrusion (2-3 mm) in the aorta.A 15-mmhg residual gradient was documented and postdilatation (10 atm) was performed with a 10x40-mm powerflex pro balloon.At this point, a dissection was noticed at the distal edge of the stent, which extended distally involving the ostium of the left vertebral artery.The dissection was immediately sealed with a second overlapping 8x30 mm smart stent (, in order to prevent extension into the vertebral circulation.To avoid stent malapposition at the overlap region, a final balloon postdilatation (10 atm) was performed in the proximal lsa with a 10x40- mm powerflex pro balloon.Final angiography showed an optimal result, without residual pressure gradient, and normal flow in the left vertebral artery.The patient remained asymptomatic throughout the procedure.In the following hours the patient developed intense abdominal pain refractory to conventional analgesia, accompanied by hematochezia.Physical exam and vital signs were normal.Laboratory test were remarkable for hyperlactatemia (13 mmol/l; normal values <2.2 mmol/l) with normal renal function.Mesenteric ischemia was suspected and a thoracoabdominal cta was performed.An aortic dissection extending from the origin of the lsa to the right common iliac artery was diagnosed.Detailed analysis clearly showed the relationship between the proximal edge of the stent and the origin of the dissection, which involved distally the sma.Conversely, the dissection did not extend into the ostium of celiac trunk, which was nevertheless compressed by the dissection flap.The right renal artery aroused from the true lumen while the left renal artery originated from the false lumen.Small bowel wall edema confirmed the diagnosis of mesenteric ischemia.There was also evidence of left kidney hypoperfusion, although this was mitigated by the presence of a fenestration between the two lumens in correspondence with the origin of the left renal artery.In light of the life-threatening mesenteric ischemia caused by aortic dissection, urgent percutaneous intervention on the affected splanchnic branches was performed.Under deep sedation and from a left femoral artery access (in order to assure access to the true lumen), a 6-french judkins right guiding catheter (cordis corp.) was positioned through a 45-cm sheath into the ostium of the celiac trunk.A balloon-expandable 7x18-mm racer rx bms (medtronic, minneapolis, mn) was placed at the ostial-proximal level with optimal result.Subsequently, we performed angioplasty of the ostial sma.A 6x12-mm racer rx stent was used, but due to distal migration during inflation, an overlapping 7x12-mm racer rx stent was implanted proximally with optimal result.Mesenteric ischemia rapidly subsided, and patient¿s hospital course was uncomplicated thereafter.Dual antiplatelet therapy (aspirin 80 mg daily lifelong and clopidogrel 75 mg daily for 12 months) was prescribed.One month later, the patient was free from angina or left arm claudication.However, a follow-up cta showed progressive dilatation of the descending thoracic aorta (maximum diameter: 40 mm) and thoracic endovascular aorta repair (tevar) was planned to prevent further dilatation and minimize the risk ofaortic rupture.Since coverage of the lsa was anticipated and in order to maintain blood supply to the left arm, a left carotid to lsa bypass was performed two days before tevar.Under general anesthesia, with transesophageal echocardiography guidance and through a left femoral access, tevar was performed successfully.A 6x202-mm zenith tx2 self-expandable endoprosthesis (cook medical inc.(b)(4)) was positioned slightly proximal to the lsa ostium and extending distally to the descending thoracic aorta.During the same intervention, proximal lsa occlusion was performed in order to prevent a type 2 endoleak caused by retrograde flow from the carotid bypass, which could eventually cause detachment of the endoprosthesis and proximal extension of the dissection to the aortic arch and ascending aorta (6, 7).Four 15- mm-by-40-cm interlock-35 detachable coils (boston scientific corp., (b)(4)) were successfully deployed through a left radial access.The patient was then discharged after an uncomplicated hospital course.At two month follow-up he was asymptomatic.Follow-up cta showed complete exclusion of the aortic aneurysm and total occlusion of the proximal lsa, with distal flow through the carotid-subclavian bypass.The product was not returned for analysis.A review of the manufacturing records could not be conducted without the lot number.Dissection is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.The physical manipulation inherent in the stent implantation procedure intentionally disrupts the vessel plaque and intima in an effort to reconstruct viable patent vasculature and treat the atherosclerotic disease process.The subsequent mesenteric ischemia and descending thoracic aortic dilation appear to be directly related to the initial dissection event.There is no evidence to suggest there were any manufacturing issues that contributed to the reported events and these events do not represent device malfunctions.Review of the available information suggests that vessel / lesion characteristics and possibly procedural factors may have contributed to this event.Therefore, no corrective actions will be taken.This is one of 2 products involved with the reported event and are associated manufacturer report numbers 9616099-2015-00219 and 9616099-2015-00220.
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