MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number T505 |
Device Problems
Patient Device Interaction Problem (4001); Central Regurgitation (4068)
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Patient Problems
Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 10/28/2022 |
Event Type
Injury
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Event Description
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Literature was reviewed regarding surgical and transcatheter aortic valve replacement for severe aortic stenosis in low-risk elective patients.The study population included 2393 patients who were predominantly male. multiple manufacturer¿s devices were implanted in the study population; approximately 1424 patients were implanted with a medtronic evolut r (n=163) transcatheter valve or hancock ii surgical valve (71.5% of 1764 savr patients, n=1261). deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths. among all patients adverse events included: severe aortic regurgitation, bleeding requiring intervention, myocardial infarction, acute kidney injury, wound infection, stroke, and arrhythmia requiring permanent pacemaker implant. no further information pertaining to medtronic products was noted.
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Manufacturer Narrative
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Citation: kowalowka et al.Surgical and transcatheter aortic valve replacement for severe aortic stenosis in low-risk elective patients: analysis of the aortic valve replacement in elective patients from the aortic valve multicenter registry.J thorac cardiovasc surg.2022 oct 28:s0022-5223(22)01148-5.Doi: 10.1016/j.Jtcvs.2022.10.026.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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