MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number D-EVPROP2329US |
Device Problems
Inaccurate Delivery (2339); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
Injury
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the physician intended to recapture the valve however deployed the valve instead.The physician pulled the device back prior to the tabs fully releasing.The valve dislodged.Subsequently, a second valve was implanted successfully.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Concomitant medical products: the main component of the system.Other relevant device(s) are: product id: evproplus-29us, serial#: (b)(4), ubd: 20-jul-2023, udi#: (b)(4).Product analysis: no product was returned.Conclusion: without 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 subject delivery catheter system (dcs) was discarded by the customer and therefore was unable to be returned for analysis.Procedural images were not provided for review.The reported event indicates that the physician intended to recapture the valve however deployed the valve instead.Various factors can influence inaccurate delivery including patient anatomy or physician technique.In this case, the inaccurate delivery event is due to the physician accidentally deploying the valve when attempting recapture.Inaccurate delivery does not typically indicate a device malfunction or a failure to meet manufacturing specifications and there is no information to suggest a device quality deficiency that may have caused or contributed to this event.The reported event also indicates that the physician pulled the device back prior to the tabs fully releasing and the valve dislodged.Potential factors that can influence dislodgement include tension applied on the dcs during positioning, calcification levels and shape of the native anatomy.In this case, the physician pulled the device back prior to the tabs fully releasing and the valve dislodged.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications and there is no information to suggest a device quality deficiency that may have caused or contributed to this event.A device history review is not required as the product event does not indicate a potential manufacturing issue.Updated a1.Updated h6.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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