MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-26US |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2021 |
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.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 during the implant of this 26 mm transcatheter bioprosthetic valve into a previously implanted surgical aortic valve (sav), on the third deployment attempt, upon release, the transcatheter valve dislodged into the ascending aorta.The transcatheter valve was snared just below the great vessels.A second transcatheter bioprosthetic valve was successfully implanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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