MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number D-EVPROP2329US |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Stroke/CVA (1770); Visual Impairment (2138); Numbness (2415); Thromboembolism (2654); Vascular Dissection (3160)
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Event Date 02/17/2022 |
Event Type
Injury
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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.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 following the implant of this transcatheter bioprosthetic valve, a type b localized aortic dissection was observed.Per the physician, the dissection likely occurred while preforming a pre-implant balloon aortic valvuloplasty (bav) or while inserting the non-medtronic guidewire, however the exact cause of the dissection was unknown.The patient was placed under observation.No further treatment for the dissection was performed.Hemodynamics showed good results and a functioning valve.Three days following the valve implant procedure, the patient reported numbness on the left side of the body.A computed tomography (ct) was performed which revealed a cerebral infarction.The infarction was diagnosed due to atherothrombosis, and it was believed that the "tumor" migrated due to catheter operation.It was reported that the numbness subsided, however a slight visual impairment remained.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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