MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTR-29

Device Problems Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Calcium Deposits/Calcification (1758); Cardiac Arrest (1762); Dyspnea (1816); Unspecified Infection (1930); Pneumonia (2011); Low Cardiac Output (2501); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/18/2022

Event Type  Death  

Manufacturer Narrative

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.Outcomes to adverse event & date of event: estimated based on the information provided.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.

Event Description

Medtronic received information that approximately 4 years and 10 months following the direct aortic implant of this transcatheter bioprosthetic valve, the patient was hospitalized for 18 days due to dyspnea and bilateral pneumonia.Three days after the hospitalization cardiac decompensation was identified.An echocardiogram identified an ejection fraction of 50-55%, dilation of the left atrium, moderate mitral insufficiency, moderate tricuspid insufficiency, and a pressure gradient max of 48 millimeters of mercury (mmhg).Additionally, there was a ¿floating ball formation¿ (vegetation) below the cusp and formation around the transcatheter valve (abscess).The n-terminal pro hormone b-type natriuretic peptide (nt-probnp) measured 17000 and the c-reactive protein (crp) measured 128.There was a small paravalvular leak (pvl) and severe central aortic regurgitation.Calcification was present from the left coronary cusp (lcc) and non-coronary cusp (ncc) into the left ventricular outflow tract (lvot).The patient was scheduled for a valve revision procedure, date not specified, for a non-medtronic valve to be implanted.However, the patient had died approximately 8 weeks following the cardiac decompensation.

Event Description

Additional information was received which reported that the transcatheter bioprosthetic valve was implanted into a native valve.The implant depth at the initial implant procedure was reported as 3 mm on the non-coronary cusp (ncc) and 5.5 mm on the left coronary cusp (lcc).Endocarditis was never confirmed, however was highly suspected by the physicians.The patient has ulcus cruris, which may have contributed to the possible endocarditis.The patient was prescribed ceftriaxone for 30 days, followed by linezolid and meropenem.The patient was also prescribed diuretics at the time of the cardiac decompensation.Per the physician, the degenerated valve contributed to the patient death.The cause of death was suspected as cardiac arrest.

Manufacturer Narrative

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.

Manufacturer Narrative

Conclusion: no images of the implantation procedure or the implanted valve were available for medtronic review and the valve was not returned to medtronic for product analysis.Elevated gradients can be related to valve related factors (degeneration, thrombus, calcification, etc) or non-valve related factors (left ventricular outflow tract (lvot) obstruction, patient pressures, left ventricle (lv) dysfunction, etc).A pre-implant balloon aortic valvuloplasty (bav) was performed.The patient¿s calcification of left coronary cusp (lcc) and non-coronary cusp (ncc), as well as the vegetation and abscess present were likely contributing factors to the elevated gradients.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.Regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.Calcification of the leaflets may be a potential cause of the reported regurgitation.Conduction disturbances are known potential adverse effects per the device instructions for use (ifu).Factors that may impact the development of conduction disturbances include baseline conduction defects and anatomical considerations.Endocarditis was never confirmed, however was highly suspected by the physicians.The patient has ulcus cruris, which may have contributed to the possible endocarditis and infection.Endocarditis and 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.Infection leads to presence of biofilm on surgical implants which often requires removal of the device as the biofilm is difficult to resolve medically (3,54).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.Endocarditis is a known potential adverse event listed in the ifu and addressed in the current risk management file.The patient was prescribed ceftriaxone for 30 days, followed by linezolid and meropenem.The cause of death was suspected to be cardiac arrest and an explant was not performed.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.Review of the device history record (dhr) and sterility record for this device found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.No further action is recommended at this time.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 (3) de allori et al.(2006).Antimicrobial resistance and production of biofilms in clinical isolates of coagulase-negative staphylococcus strains.Biol.Pharm.Bull.29 (8): 1592¿1596.(4) salyers, abigail a.And whitt, dixie d.(2002).Bacterial pathogenesis: a molecular approach, 2nd ed.Washington, d.C.: asm press 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.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15737621
• MDR Text Key: 303133888
• Report Number: 2025587-2022-03080
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Date Device Manufactured: 09/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male