MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number MDT-TRANS VALVE |
Device Problems
Perivalvular Leak (1457); Patient Device Interaction Problem (4001)
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Patient Problems
Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 12/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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Citation: ikuta et al.Impact of serum haemoglobin-to-creatinine ratio after transcatheter aortic valve implantation.Open heart.2023 dec 2;10(2):e002419.Doi: 10.1136/openhrt-2023-002419.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.Select patient information cannot be included in regulatory report due to regional privacy regulations.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.
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Event Description
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Literature was reviewed regarding impact of serum hemoglobin-to-creatinine ratio after transcatheter aortic valve implantation.The study population included 458 patients. multiple manufacturer¿s devices were implanted in the study population; an undisclosed number of patients were implanted with a medtronic evolut r or evolut pro bioprosthetic valve. 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: arrhythmia requiring permanent pacemaker implant, moderate or severe paravalvular leak, major vascular complication, bleeding complication, and congestive heart failure requiring hospitalization. no further information was provided pertaining to medtronic products.
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