MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTR-26 |
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 03/07/2024 |
Event Type
malfunction
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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve into previously implanted surgical valve, there was misalignment between the valve and the previous surgical valve.The delivery catheter system (dcs) advanced through the anatomy with no issues.Several attempts to place the valve were performed, however the valve dislodged or ended deep on the left coronary cusp (lcc) and transesophageal echocardiogram (tee) revealed interference with the mitral valve.The guide wire was changed to a super stiff non-medtronic guidewire (lunderquist) for better alignment between the valve but was unsuccessful.Pacing during the implant attempts was performed accordingly.The physician decided to abort the valve implant and implant a non-medtronic valve.No adverse patient effects were reported.
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Manufacturer Narrative
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Continuation of d10: product id l-envpro-14 (lot: 0011494814); product type: 0195-heart valves; implant date ; explant date product id envpro-14 (lot: 0012052274); product type: 0195-heart valves; implant date ; explant date product id lunderquist (lot: ); product type: guidewire; implant date ; explant date product id hankock surgical valve(serial number: ); product type: heart valve; implant date ; explant date 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 confirmed that a pre implant balloon aortic valvuloplasty (bav) was not performed.
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Manufacturer Narrative
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Updated b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Updated h.6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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