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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Embolism (1829); Hematoma (1884); Occlusion (1984); Perforation (2001)
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Event Date 04/25/2020 |
Event Type
Injury
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Manufacturer Narrative
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Journal title: outcomes of adjunctive drug-coated versus uncoated balloon after atherectomy in femoropopliteal artery disease journal: annals of vascular surgery year: 2020 ref: doi: 10.1016/j.Avsg.2020.04.032.Patient age: average age.Sex: majority gender.Event date: date of publication.Note: journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was submitted detailing a single-center retrospective and prospective study to evaluate outcomes using drug-coated balloon (dcb) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions.115 patients with 126 limbs treated were included in the study.Medtronic¿s atherectomy device¿s silverhawk, turbohawk, and hawkone were used as well as medtronic¿s in.Pact admiral paclitaxel-coated balloon and medtronic¿s spider fx distal embolization protectiondevices during the procedure.Clinical event¿s including vascular perforations, device entrapment by stent (requiring surgical repair), flow-limiting embolization, and access site access site hematoma were reported in the population as immediate procedural outcomes.Complications were management by surgical management or conservative care.Long-term clinical outcomes reported include in-stent restenosis (isr) and target lesion revascularization (tlr).Death is reported, however no device or procedural relationship has been identified.
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Search Alerts/Recalls
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