Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
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Event Date 11/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Journal article: fractional flow reserve¿guided pci as compared with coronary bypass surgery authors: william f fear on, frederik m zimmermann, bernard de bruyne, zsolt piroth, albert h m van straten, laszlo szekely, giedrius davidavicius, gintaras kalinauskas, samer mansour, rajesh kharbanda journal: the new england journal of medicine year: 2022 reference: doi: 10.1056/nejmoa2112299.Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s) was provided.Date of event: date of publication.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 titled: fractional flow reserve¿guided pci as compared with coronary bypass surgery.The study was a multicenter, international, non-inferiority trial, where patients with three-vessel coronary artery disease were randomly assigned to undergo coronary-artery bypass grafting (cabg) or fractional flow reserve (ffr) guided percutaneous coronary intervention (pci) with current-generation zotarolimus-eluting stents.A total of 1500 patients were randomized with 757 randomly assigned to undergo pci and 743 to undergo cabg.The lesions treated included vessels with chronic total occlusion and bifurcation lesions.Patients treated with pci received either resolute integrity or resolute onyx drug eluting stents.At 1 year follow up the following end points were noted in the pci group: death from any cause, myocardial infarction, stroke, repeat revascularization, barc type 3¿5 bleeding, acute kidney injury, atrial fibrillation or clinically significant arrhythmia, definite stent thrombosis and rehospitalization within 30 days.
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Search Alerts/Recalls
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