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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aneurysm (1708); Perforation (2001); Embolism/Embolus (4438); Restenosis (4576); Insufficient Information (4580)
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Event Date 07/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Average age.Majority gender.Event date: date of article publication one-year clinical outcome and risk factor analysis of directional atherectomy followed with drug-coated balloon for femoropopliteal artery disease journal of endovascular therapy (2021) 28(6) 927¿937 10.1177/15266028211030527.If information is provided in the future, a supplemental report will be issued.
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Event Description
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This retrospective study analyzed 79 patients (83 lesions) who were treated with directional atherectomy (silverhawk and turbohawk) and non-medtronic drug-coated balloon for femoropopliteal lesions.The target limbs were on the left in 36 patients, right in 37, and bilateral in 4.Fourteen patients had previous peripheral revascularization and 10 patients had prior intervention of the target vessel.There were 73 limbs with de novo lesion, including 23, 18, and 32 with diffused stenosis, cto, and stenosis + cto, respectively.There were 10 limbs with in-stent restenosis (isr).Target lesions involved the superficial femoral artery, popliteal artery, infrapopliteal artery, and common femoral artery in 65, 39, 5 and 7 patients, respectively.Directional atherectomy was performed at the superficial femoral artery and bifurcation area of the femoral artery in 57 and 7 patients, the p2¿p3 segment of the popliteal artery or proximal area of the infrapopliteal artery in 5 patients, and the p1 segment of the popliteal artery in 28 patients, respectively.The device and procedural success rate were both 100%.All lesions were treated via intraluminal crossing, except for 8 lesions.Retrograde pedal access was used in 3 patients.A distal embolic protection device (spider fx) was deployed in 34 lesions.Before da, 24 lesions were predilated, with a mean balloon diameter of 2.6 mm.The total length of dcb per subject was 230mm.Notably, the rate of bailout stenting was only in this cohort.Infrapopliteal runoff vessel reconstruction was performed in 45 lesions.Four patients had early perioperative complications; 1 puncture site hematoma, 2 distal embolization, 1 perforation.All patients had complete 1-year follow-up data except 2 patients who had no follow-up beyond the day of intervention.During post-procedural year, one patient with a 2-cm popliteal artery diameter was treated with a non-medtronic stent-graft in the degenerated segment.Eight patients experienced a major adverse event; 7 all-cause deaths, 1 major amputation and 1 aneurysm.
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Manufacturer Narrative
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Pt age: average age.Pt gender: majority gender.Event date: date of article publication one-year clinical outcome and risk factor analysis of directional atherectomy followed with drug-coated balloon for femoropopliteal artery disease journal of endovascular therapy (2021) 28(6) 927¿937 10.1177/15266028211030527.If information is provided in the future, a supplemental report will be issued.
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Event Description
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This retrospective study analyzed 79 patients (83 lesions) who were treated with directional atherectomy (silverhawk and turbohawk) and non-medtronic drug-coated balloon for femoropopliteal lesions.The target limbs were on the left in 36 patients, right in 37, and bilateral in 4.Fourteen patients had previous peripheral revascularization and 10 patients had prior intervention of the target vessel.There were 73 limbs with de novo lesion, including 23, 18, and 32 with diffused stenosis, cto, and stenosis + cto, respectively.There were 10 limbs with in-stent restenosis (isr).Target lesions involved the superficial femoral artery, popliteal artery, infrapopliteal artery, and common femoral artery in 65, 39, 5 and 7 patients, respectively.Directional atherectomy was performed at the superficial femoral artery and bifurcation area of the femoral artery in 57 and 7 patients, the p2¿p3 segment of the popliteal artery or proximal area of the infrapopliteal artery in 5 patients, and the p1 segment of the popliteal artery in 28 patients, respectively.The device and procedural success rate were both 100%.All lesions were treated via intraluminal crossing, except for 8 lesions.Retrograde pedal access was used in 3 patients.A distal embolic protection device (spider fx) was deployed in 34 lesions.Before da, 24 lesions were predilated, with a mean balloon diameter of 2.6 mm.The total length of dcb per subject was 230mm.Notably, the rate of bailout stenting was only in this cohort.Infrapopliteal runoff vessel reconstruction was performed in 45 lesions.Four patients had early perioperative complications; 1 puncture site hematoma, 2 distal embolization, 1 perforation.All patients had complete 1-year follow-up data except 2 patients who had no follow-up beyond the day of intervention.During post-procedural year, one patient with a 2-cm popliteal artery diameter was treated with a non-medtronic stent-graft in the degenerated segment.Eight patients experienced a major adverse event; 7 all-cause deaths, 1 major amputation and 1 aneurysm.
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Search Alerts/Recalls
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