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Model Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Myocardial Infarction (1969)
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Event Date 04/23/2020 |
Event Type
Death
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Manufacturer Narrative
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Citation: silverberg d, bar-dayan a, rimon u, raskin d, fefer p, halak m.The jailed coiling technique for the treatment of penetrating ulcers and saccular aneurysms of the aortic arch.Vascular and endovascular surgery.2020;54(5):423-429.Doi:10.1177/1538574420921282.The concerto coil will not be returned as implanted in the patient.Base on the reported information there were not any device issue during the use.The events occurred in post procedure and cause was unknown.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information through literature review.There was 1 perioperative mortality.This patient, who had severe cardiac disease, presented with a symptomatic, enlarging 7-cm sa.The patient underwent an axillary¿axillary bypass followed by tevar and coiling of his sa.The surgery was uneventful, however he expired on postoperative day 2 due to an extensive myocardial infarction.Technical success was achieved in all patients, resulting in obliteration of the aneurysm lumen.No patient suffered from a perioper ative cerebrovascular event, spinal cord ischemia or inadvertent coverage of a supra-aortic vessel.In all cases, the coils (concerto coils) were delivered accurately, with no events of coil migration into the aorta.9 patients underwent treatment for penetrating aortic ulcers (paus) and saccular aneurysms (sas) of the arch.Mean age was 70 years (range 60-79) and all patients were male.
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Search Alerts/Recalls
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