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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number EVPROPLUS-34US |
| Device Problems
Degraded (1153); Incomplete Coaptation (2507); Activation Failure (3270); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008); Central Regurgitation (4068)
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| Patient Problems
Arrhythmia (1721); Chest Pain (1776); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Fatigue (1849); Fever (1858); High Blood Pressure/ Hypertension (1908); Chills (2191); Cusp Tear (2656); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Cough (4457)
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| Event Date 03/03/2020 |
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Event Type
Injury
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Manufacturer Narrative
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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 three years and seven months following the implant of this transcatheter bioprosthetic valve, the patient noticed changes in his valve.The patient reported that the valve sounded different, and that walking up a slight incline was causing shortness of breath, despite the patient climbing a ski hill with no problems a week prior.Upon echocardiogram examination and consultation with physician, according to the patient, their physician stated "that one of the valve's leaflets is no longer attached and is "flopping around"", causing "blood to leak backwards into the patient's heart".According to the patient, the physician recommended open heart surgery to explant the valve and replace with a surgical valve.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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 that a cuspal tear/flail leaflet did not occur, and the cause of the leaflet issue was due to structural valve dysfunction.Per the physician, the valve showed deterioration causing central aortic regurgitation.Subsequently, the patient reported that the transcatheter valve was explanted, and a surgical aortic valve was implanted.No additional adverse patient effects were reported.
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Event Description
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Additional information was received that severe central aortic regurgitation occurred.No additional adverse patient effects were re ported.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Updated a2.Updated a4.Updated b3.Updated b5.Updated b7.Updated h6.Product analysis: two static images were provided for review.The event refers to an evolut explanted surgically in which the leaflets appear to be detached.The cause of the possible detachment is unknown.Of note, as stated in the instructions for use (ifu), potential risks associated with the implantation of the evolu pro+ bioprosthesis may include, but are not limited to, the following: prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-ofround configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement.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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Event Description
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Additional information was received that during the index procedure/implant procedure of this transcatheter bioprosthetic valve, a confida guidewire was used during implant.A pre implant balloon aortic valvuloplasty (bav) was performed with 26 mm non-medtronic (z-med) balloon.After the valve was deployed, the valve was noted to be ¿under deployed¿ and was post dilated with a 28 mm non-medtronic (z-med) balloon under rapid pacing conditions.Following the balloon aortic valvuloplasty (bav), the aortic valve max pressure gradient (pg) was 7.5 mmhg and the mean pg was 4.5 mmhg with an aortic valve area of 2.23 cm2.A minor vascular complication following pigtail catheter removal was noted, which required an additional closure device (perclose) to achieve hemostasis, with additional manual pressure.This vascular complication had an unknown relationship tothe delivery catheter system (dcs).Following the valve implant, the patient demonstrated a prolonged pr interval and rare dropped p waves.A temporary pacemaker was inserted as a backup and the patient was admitted to the cardiac care unit (ccu) for observation overnight.Following the valve implant, no aortic insuffic iency was observed.One day following the valve implant, an electrocardiogram (ecg) was performed and showed right bundle branch block (rbbb) and st elevation.An echocardiogram was also performed.Per the echocardiogram, there was no hemodynamically significant aortic stenosis identified.The transcatheter aortic valve (tavr) had a mean av gradient of 9 mmhg and a vmax of 2.1 m/sec; physician noted these findings implied a normal prosthesis function.A transthoracic echocardiogram (tte) also identified trace tricuspid regurgitation.Approximately three years and three months following the valve implant, trivial aortic regurgitation was noted with a left ventricle ejection fraction of 65%.Approximately three years and sevenmonths following the valve implant, the patient stated "they were doing well and then suddenly noted feeling short of breath (sob) and dyspneic.A heart murmur could be heard.Had one day of feverish and chilled; since then nothing.The patient noted feeling bloated, fatigued and coughing." an echocardiogram was performed which showed a well seated valve with severe aortic regurgitation due to valve degeneration.The patient then presented with chest pain and hypertension and heart palpitations.An ecg was performed which showed sinus rhythm with av dissociation, wide qrs rhythm with occasional premature ventricular complexes (pvcs) and right bundle branch block (rbbb).Per the physician, the aortic valve le ak resulted in sob and acute systolic congestive heart failure.Upon hospital admission, mobile echoes within the prosthesis suggest a flail leaflet.Tavr valve with highly mobile flail, possibly torn, leaflet with resulting severe regurgitation.The patient was taken to the operating room and underwent a tavr explant.The tavr was explanted, however the physician reported the valve was complex to remove.An additional 20 minutes were needed to remove the valve.Once the tavr was removed, the native valve was also removed.The native valve was noted to be heavily calcified with a lot of calcium extended into the lv outflow.The patient was sized for a 29 mm medtronic mosaic surgical aortic valve (sav).The aortic root had multiple areas whore it had torn from removing the tavr.The physician used 5-0 prolene mattress sutures to tack these areas of the wall back.The sav was successfully implanted and it was noted that the patient tolerated the procedure well and then was transferred to cvicu intubated and in stable condition.The patient was weaned from the ventilator and extubated without difficulty.No additional adverse patient effects were reported.
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