MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-26 |
Device Problem
Activation Problem (4042)
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Patient Problems
Chest Pain (1776); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Cardiovascular Insufficiency (4445)
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Event Date 10/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: evproplus-26, serial/lot #: (b)(4), ubd: 06-jun-2023, udi#: (b)(4).Product analysis: both valves were discarded, 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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Event Description
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Medtronic received information that prior to use of this transcatheter bioprosthetic valve, the valve was loaded properly with overlapping down to approximately the third node.A non-medtronic (safari) guidewire was used and pre-dilatation with an 18 millimeter (mm) balloon under rapid pacing was performed.Cusp overlap technique (cot) was used and the balloon was not able to open up the native bicuspid aortic valve as the balloon migrated upwards during inflation.Several unsuccessful attempts were made, however the balloon moved upward on each attempt.The valve was attempted to be deployed and it was reported to be under expanded but not infolded.The valve was recaptured and deployed a second time, but remained under expanded.Poor hemodynamics was reported.The valve was recaptured and withdrawn from the patient.An additional attempt to predilate using a 20 mm balloon, but resulted in the balloon migrating upwards.The same valve and delivery catheter system (dcs) were re-inserted, however the valve remained under expanded on the third deployment attempt.The valve was recaptured and withdrawn from the patient.The physician attempted to predilate the patient's valve again, however the balloon continued to move upwards on every attempt as a result of the tight stenosis with raphae.A second transcatheter valve was loaded on a second dcs.The fluoroscopic load check revealed crown overlapping to approximately the second node.The valve was attempted to be deployed three separate times but the valve appeared under expanded like the deployment attempts with the first valve.Pacing was performed between 120-160 beats per minute (bpm).The physician decided to stop the procedure due to poor hemodynamics and log session of pacing and under expansion of the valve.When checking the patient's gradient after the unsuccessful attempts, the gradient had decreased from 80 to 40 mmhg.Elevated troponin levels were reported and a myocardial infarction was suspected.Chest pain was also reported.Per the physician, the myocardial infarction may have been caused by the several bav attempts and recaptured.The valve(s) also likely contributed to the myocardial infarction due to the under expansion.No treatment was required for the myocardial infarction.The patient was reported to be in "good status" without complications.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Conclusion: two static images were submitted to medtronic for review.The patient summary was not provided.The images provided show an under-expansion in the frame of the valve, however, it is only one view and it is not possible to make an evaluation without the angiogram and computed tomography (ct) or preview summary of the aortic root.According to the instructions for use (ifu), after 3 attempts, the valve needs to be removed from the patient.For another attempt, a new valve and delivery catheter system (dcs) should be used.The device history records for both valves were reviewed and showed that these products met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Per the device ifu, in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant balloon dilation of the bioprosthesis may improve valve function and sealing.To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation.The balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.Refer to the specific balloon catheter manufacturer's labeling for proper instruction on the use of balloon catheter devices.With limited information available, a conclusive cause of the constrained valve could not be determined.Low cardiac output (hemodynamic issue) can be related to valve related (degeneration, thrombus, calcification, etc.) or non-valve related factors (lvot obstruction, patient pressures, lv dysfunction, etc.).It is unknown if the patient comorbidities played a role in the reported low cardiac output.Without review of echocardiographic imaging, an assignable root cause of the low cardiac output cannot be determined.Without angiograms and computed tomography (ct) or preview summary of the aortic root, the cause of the reported elevated troponin level could not be determined with limited information.Myocardial infarction is a known potential adverse effect per the device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally functioning device or model implant procedure.In this case, no treatment was required for the myocardial infarction.Per the physician, the myocardial infarction may have been caused by the several bav attempts and recaptures.The valve also likely contributed to the myocardial infarction due to the under expansion.However, this could not be confirmed by medtronic, so a conclusive cause of the infarction could not be determined with limited information available.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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