MEDTRONIC HEART VALVES DIVISION HANCOCK AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 242 |
Device Problems
Partial Blockage (1065); Patient-Device Incompatibility (2682)
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Patient Problems
Arrhythmia (1721); Atrial Fibrillation (1729); Bradycardia (1751); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Foreign Body Reaction (1868); Tachycardia (2095); Tricuspid Valve Stenosis (2113); Fibrosis (3167); Heart Failure/Congestive Heart Failure (4446)
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Event Date 07/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Citation: citation: spring a.; et al.The importance of pre-operative imaging and 3-d printing in transcatheter tricuspid valve-in-valve replacement.Cardiovasc revasc med.2021 jul;28s:161-165.Doi: 10.1016/j.Carrev.2020.07.031.Pmid: 32798117.Epub 2020 jul 28 earliest date of publication used for date of event.Medtronic products referenced: hancock (pma# p870078, product code: dye).Earliest approved product used for product code and pma#.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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Event Description
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Medtronic received information via literature regarding a 44- year-old female patient with a history of systemic lupus erythematosus (sle), renal insufficiency, pulmonary fibrosis, cutaneous vasculitis and non-ischemic cardiomyopathy.The patient developed bacterial endocarditis and underwent surgical tricuspid valve replacement using a 25-mm medtronic hancock bioprosthesis and mechanical mitral valve replacement using a non-medtronic product (unique device identifier numbers not provided).The patient presented to the hospital 18 years later with signs of heart failure, including dyspnea and palpitations.She was found to have new-onset atrial fibrillation with rapid ventricular rate and later developed tachy-brady syndrome, which was difficult to control with medication, requiring permanent pacemaker implantation (ppmi).During hospitalization, the patient underwent transthoracic and transesophageal echocardiography (tte/tee), revealing severe tricuspid stenosis involving fibrotic leaflets with reduced motion and severe bi-atrial enlargement.The patient underwent transcatheter valve-in-valve replacement (tvivr) using a 23-mm non-medtronic bovine bioprosthesis.One-month and 5-year follow-ups showed no issues with the valve replacement and improvement of the patient¿s symptom.No additional adverse patient effects or product performance issues were reported.
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Manufacturer Narrative
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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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