MEDTRONIC HEART VALVES DIVISION MEDTRONIC HALL PROSTHETIC HEART VALVE; HEART-VALVE, MECHANICAL
|
Back to Search Results |
|
Model Number M7700 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Atrial Fibrillation (1729); Cardiovascular Insufficiency (4445); Mitral Valve Insufficiency/ Regurgitation (4451)
|
Event Date 05/30/2022 |
Event Type
Injury
|
Event Description
|
Literature was reviewed regarding mitral valve-in-valve implant of a balloon-expandable valve guided by three-dimensional printing. the study population included six patients, three of whom were implanted with a degenerated medtronic hall mechanical valve.Among all patients adverse events included: mitral regurgitation, tricuspid regurgitation, atrial fibrillation, and hemodynamic instability requiring intervention in the form of mitral valve-in-valve implant.No additional adverse patient effects were noted.
|
|
Manufacturer Narrative
|
Citation: mao et al.Mitral valve-in-valve implant of a balloon-expandable valve guided by 3-dimensional printing.Front cardiovasc med.2022 may 30;9:894160.Doi: 10.3389/fcvm.2022.894160.Ecollection 2022.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.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.
|
|
Event Description
|
Additional information received from the physician/author stated: 1) the medtronic valves were not clearly identified during surgical intervention, 2) any valve-related decay was related to the patient's internal environment, timing of surgery, postoperative maintenance, and follow-up medication, and 3) the focus of the article was not aimed at any manufacturer, but rather the natural physiological decline of the patient.No further details were provided.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|