MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number D-EVPROP2329US |
Device Problems
Positioning Problem (3009); Patient Device Interaction Problem (4001)
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Patient Problem
Stroke/CVA (1770)
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Event Date 07/28/2022 |
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, into a patient with an existing failed bioprosthetic non-medtronic valve, three recaptures were performed due to suboptimal positioning.Approximately twelve hours following the valve implant, an ischemic stroke occurred.No patient symptoms or diagnostic technique to confirm a stroke were reported.Per the physician, the medtronic devices may have contributed to the stroke indirectly as a result of the multiple recaptures.The physician further indicated 'matter' from the existing valve may have dislodged during the recaptures and caused the stroke.The patient was expected to fully recover.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Concomitant medical products: product id: evproplus-26us, serial #: (b)(4), ubd: 22-feb-2024, udi#: (b)(4).Product analysis: the valve remains implanted, the dcs was discarded, and no procedural images were submitted for review; therefore, no product analysis can be performed.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.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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Updated b5.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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Event Description
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Additional information was received from the physician which reported that the patient did have a lot of calcium of the native valve but no other factors contributing to the stroke.
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Search Alerts/Recalls
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