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Model Number 500DM27 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Calcium Deposits/Calcification (1758); Insufficient Information (4580)
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Event Date 09/19/2022 |
Event Type
Injury
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Event Description
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Medtronic received information that during the implant of this 27mm mitral mechanical valve, it was reported that "after imaging, it did not cycle one of the leaflets blocked by calcium", the valve was explanted and replaced with a non-medtronic bioprosthetic valve.It was reported that prior to implant of the 27mm mitral mechanical valve, extensive calcification of the leaflet and subvalvular posterior fusion of chordae tendineae by calcification was noted but the physician choose not to decalcify or remove the posterior leaflet because of the risk of atrioventricular disjunction.No additional adverse patient effects were reported.
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Manufacturer Narrative
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No product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Conclusion: the analysis and investigation is in progress.A supplemental report will be submitted after completion of the investiga tion.D9: device available for evaluation: updated h6: coding updated 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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Manufacturer Narrative
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Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve appeared discolored showing evidence of blood contact.Both leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both leaflets were received in the closed position.A blue actuator was used to test leaflet movement, the leaflets moved without difficulty.Remnants of dried blood were noted along the orifice and both hinge mechanisms.The valve was cleaned using isopropyl alcohol.After the valve was cleaned, the orifice appeared intact with no evidence of damage.Both inflow and outflow valve hinge mechanisms appeared intact.Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.H3: device evaluated? updated h6: coding updated 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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Manufacturer Narrative
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Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The cause of the leaflet motion was stated to be due to calcium on the patient valve.H6: updated 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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Search Alerts/Recalls
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