MEDTRONIC HEART VALVES DIVISION MOSAIC ULTRA PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 305U2J23 |
Device Problems
Reflux within Device (1522); Material Separation (1562); Incomplete Coaptation (2507); Material Split, Cut or Torn (4008)
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Patient Problems
Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Cusp Tear (2656); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 04/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Citation: koga k.; et al.Commissural dehiscence of aortic mosaic bioprosthesis: a case report.Heart (shinzo), 2022 january 20; 54( 6):686-690.Earliest date of publication used for date of event.Medtronic products referenced: mosaic (pma# p990064, 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 an 85-year-old male patient with severe bicuspid aortic valve stenosis who underwent implant of a 23-mm medtronic mosaic aortic bioprosthesis fourteen years prior (unique device identifier numbers not provided).The patient presented to the hospital reporting positional/exertional dyspnea at home.Examination noted hypertension, with lung rales on chest auscultation.Echocardiography and cardiac catheterization noted worsened aortic regurgitation from prior exams with evidence of heart failure.The patient underwent surgical aortic valve replacement and it was noted the mosaic valve had right coronary cuspal tearing with dehiscence.Post-operative recovery was uneventful and the patient's symptoms resolved.No additional adverse patient effects or product performance issues were reported.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information obtained from follow-up with the author and a company representative.This event occurred outside the u.S.All information provided is included in this report.The device was previously reported in in a timely manner in 3500a regulatory report# 2025587-2021-02429 and submitted on 2021-08-02.The device was explanted and returned to the manufacturer for product analysis/investigation, which was completed on 2022-03-28 and regulatory report# 2025587-2021-02429 was submitted with the findings.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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