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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number EVPROPLUS-26 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Aspiration/Inhalation (1725); Stroke/CVA (1770); Dyspnea (1816); Paralysis (1997); Sepsis (2067); Dysphasia (2195); Low Oxygen Saturation (2477)
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| Event Date 12/09/2022 |
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Event Type
Death
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Manufacturer Narrative
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Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn 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.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 twenty-five days following the implant of this transcatheter bioprosthetic valve, the patient experienced a right sided stroke and hospitalization was required.The patient was unable to speak.A brain computed tomography (ct) was performed.Permanent impairment was reported but no further details were provided.A score of 15 on the glasgow coma scale (gcs) was reported.Reversal of direct oral anticoagulants (doac), glyceryl trinitrate (gtn) infusions, along with routine blood draws were performed.Referrals to cardiology and neurology surgeons noted.Hourly neurology and clinical observations were performed.The patient was septic and had aspirated.The patient's status was initially reported to be recovering/resolving.However, 11 days following the onset, the patient died.Per the physician, the event was possibly related to the valve and the valve procedure.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.
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Event Description
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Additional information was reported the stroke was a spontaneous intracerebral hemorrhage.The primary reason for rehospitalization was the right sided weakness and the inability to speak.The previously reported permanent impairment was referring to the inability to speak.The treatment for the sepsis included coagulation and diuretic medication.The cause of death was reported as stroke.
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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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Analysis: the device history review (dhr) and sterility record review was performed on the device and all process parameters were within specification as outlined in applicable procedures and specifications.All materials used were as per the requirements of the dhr.All processes were carried out as per relevant procedures and device met specifications.Each sterilization procedure and testing plan for sterilization, bioburden and endotoxins was performed with successful results, no abnormality was founded during the sterility record reviewed.No non-conforming material record (ncmr) or deviations referenced on the dhr were identified.Dhr review did not show any deviations in the manufacturing process.Conclusion: stroke is a known potential adverse effect per the device instructions for use (ifu), with a variety of factors that could influence its onset.A conclusive root cause of the stroke could not be determined.Infections that occur more than 12 months after the implant procedure are known as late-stage prosthetic valve endocarditis and are largely community acquired with pathogens that are more commonly associated with native valve endocarditis (1,2).The sterilization process used by medtronic, has a microbicidal effect on a wide range of microorganisms; it also has demonstrated the ability to inactivate the biological indicator, bacillus atrophaeus atcc 9372 which is representative bioburden for the microbial flora found in medtronic¿s manufacturing-controlled environment.In addition, the organism type for enterococcus bacteria, which are gram positive non-spore forming rods, has been found to be more susceptible to the effects of the sterilization process than the organism used to validate the sterilization process.Therefore, it was unlikely that the endocarditis originally came from the device and/or manufacturing valve process.Based on the information available, a conclusive root cause could not be determined, but it is unlikely that the infection was attributed to the device or the manufacturing process.Infection is a known potential adverse event listed in the ifu and addressed in the current risk management file.The cause of death was reported as stroke.Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a tav is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.With the information available, a conclusive relationship between the device and the death could not be established.(1) mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001 (2) karchmer aw: infective endocarditis.In libby p, bonow ro, mann d, et al (eds): braunswald's heart disease: a texbook of cardiovascular medicine, 8th ed.Philadelphia, elsevier, 2008, pp 1713-1733 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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Manufacturer Narrative
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Updated data: b5, h10.Conclusion: a medical safety review of the reported spontaneous intracerebral hemorrhagic stroke, dysphagia, dysarthria, sepsis, paralysis, and death was performed.Based on the information provided, it was likely that the primary event of spontaneous intracerebral hemorrhagic stroke leading to paralysis, dysphagia, dysarthria, and death were unrelated to the device.All adverse events and severities noted in this event are documented risks and within the instructions for use (ifu).Stroke is a known potential adverse effect per the device ifu, with a variety of factors that could influence its onset.A conclusive root cause of the stroke could not be determined.Infections that occur more than 12 months after the implant procedure are known as late-stage prosthetic valve endocarditis and are largely community acquired with pathogens that are more commonly associated with native valve endocarditis (1,2).The sterilization process used by medtronic, has a microbicidal effect on a wide range of microorganisms; it also has demonstrated the ability to inactivate the biological indicator, bacillus atrophaeus atcc 9372 which is representative bioburden for the microbial flora found in medtronic¿s manufacturing-controlled environment.In addition, the organism type for enterococcus bacteria, which are gram positive non-spore forming rods, has been found to be more susceptible to the effects of the sterilization process than the organism used to validate the sterilization process.Therefore, it was unlikely that the endocarditis originally came from the device and/or manufacturing valve process.Based on the information available, a conclusive root cause could not be determined, but it is unlikely that the infection was attributed to the device or the manufacturing process.Infection is a known potential adverse event listed in the ifu and addressed in the current risk management file.The cause of death was reported as stroke.Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a transcatheter aortic valve (tav) is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.Additional information indicated that the valve was working as expected at the time the event and had not contributed to the septic state.This confirmed that the valve was not associated with the sepsis and was likely unrelated to the events.With the information available, a conclusive relationship between the device and the death could not be established.(1) mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001 (2) karchmer aw: infective endocarditis.In libby p, bonow ro, mann d, et al (eds): braunswald's heart disease: a texbook of cardiovascular medicine, 8th ed.Philadelphia, elsevier, 2008, pp 1713-1733 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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Event Description
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Additional information was received which indicated that the valve was working as expected at the time the event.Additionally, the valve had not contributed to the septic state.An autopsy was not performed.
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Manufacturer Narrative
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Updated data: b5.B7.H6.Patient codes added.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.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 following the valve implant procedure, the patient had significant improvement in exercise tolerance.The patient's condition changed acutely more than three weeks after valve implant.The patient was transferred by emergency medical services to the hospital approximately 12 hours following presentation of symptoms.During transit, the patient had difficulty breathing and required supplemental oxygen.Upon neurological assessment, the patient had right facial weakness, and no movement of the right arm and leg.The patient was non-responsive to menace on the right side, had tactile inattention to the right side, and a gaze preference to the left.A computed tomography scan of the brain showed a large left thalamocapsular intracerebral hemorrhage with intraventricular extension.The patient failed the water swallow screen.The patient's gcs score had dropped three points from baseline.Despite medical care, the patient deteriorated and subsequently died.It was noted by hospital documentation for mortality specific triggers for structured judgement review that death was expected during the patient's hospital admission.Per the physician, the cause of death was due to spontaneous intracerebral hemorrhage; secondary cause of death was atrial fibrillation and heart failure.An autopsy was not performed.
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