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Model Number 505DA24 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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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Medtronic received information that "in the process of suturing the lower valve of the mechanical valve, the valve leaflet fell off".No intervention or adverse patient effects were reported.It was reported that the blue actuator was not used to test leaflet motion during the procedure.It was stated that the valve had not been sutured or rotated within the annulus when the valve leaflet detached.The valve was replaced with a non-medtronic mechanical valve.No adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that the valve had not been sutured or rotated within the annulus when the valve leaflet detached.It was reported that the valve was replaced with a non-medtronic mechanical valve.No adverse patient effects were reported.Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve remained attached to a size 24 aortic holder; valve and holder showed evidence of blood contact.Small needle holes on the sewing ring show placement of implantation sutures.As received, one of the leaflets was still attached to the valve.A detached leaflet was returned in two pieces.Using a blue actuator to test leaflet movement, the attached leaflet moved without difficulty.The attached leaflet was intact with no evidence of damage such as cracks and/or surface.The detached leaflet was received broken in two pieces.The pieces of the valve were repositioned; a chipped area was noted on both pieces of the leaflet¿s edge.The chip suggests possible grasping by an instrument (e.G.: forceps).The orifice was intact with no evidence of damage.Both inflow and outflow valve hinge mechanisms were intact.Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.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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Conclusions: 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.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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