MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number ENVPRO-14 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: upon receipt at medtronic¿s quality laboratory, the handle components detached from the delivery catheter system (dcs).The device was received with the capsule partially opened.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.The capsule appeared intact with no evidence of damage.The inner member shaft and spindle hub appeared intact with no evidence of damage.Both tab 3 and tab 4 of the male actuator component were observed to have been detached from the component.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 reported event indicates that upon removing the dcs from its packaging prior to loading, a deployment knob (actuator) separation was noted.The subject dcs was returned to medtronic for analysis.The device was received with the handle components detached from the dcs, confirming the reported event.Both snap fit tabs of the male actuator component were observed to have been detached from the component.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.A capa was initiated to investigate the root cause of actuator separation events.No other damage was present on the returned dcs.The dcs was not used for implant and another dcs was used to complete the procedure.No adverse patient effects were reported.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 that prior to the implant of this transcatheter bioprosthetic valve, a delivery catheter system (dcs) actuator separation was noted after removing the dcs from the paper outer cover box when the loading procedure started.The dcs was not used for implant and another dcs was used to complete the procedure.No adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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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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