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

Model Number CRS

Device Problem Perivalvular Leak (1457)

Patient Problems Abscess (1690); Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Low Cardiac Output (2501); Embolism/Embolus (4438); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 06/14/2022

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding infective endocarditis (ie) following surgical aortic valve replacement (savr) and transcatheter aortic valve replacement (tavr).All data was retrospectively collected from a single center between january 2013 and december 2020.A total of 120 patients who underwent surgery for ie following savr (n = 98) and tavr (n = 22) were included in the study population.In the tie (ie following tavr) group, 19 patients had been implanted with a non-medtronic transcatheter valve, while the remaining 3 patients were previously implanted with a medtronic corevalve transcatheter valve.No unique device identifier numbers were provided.The tie group was predominantly male with a median age of 77 years.In the tie group, the authors noted pacemaker and atrial fibrillation in table 1 (baseline parameters prior to undergoing surgery for ie).The need for permanent pacemaker implant and the occurrence of atrial fibrillation may have been associated with the tavr valves or the tavr implant procedure.In the tie group, the duration between tavr and onset of ie was a median 1.2 years (0.4 to 2.8 years).Prior to performing surgery for ie, the authors observed the following adverse effects: cerebral emboli, low cardiac output syndrome, decreased left ventricular ejection fraction, paravalvular leakage, aortic stenosis, mild to severe aortic regurgitation, mild to severe mitral regurgitation, mild to severe tricuspid regurgitation, pulmonary hypertension, vegetations, and abscess.In all cases, the tavr valves were explanted and replaced with either a biological or mechanical prosthesis.In the tie group, 2 in-hospital deaths occurred following surgery for ie.No statement was made suggesting a causal or contributory relationship between corevalve and the deaths.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: saha s, et al.Surgery for aortic prosthetic valve endocarditis in the transcatheter era.Journal of clinical medicine.20 22 jun 14;11(12):3418.Doi: 10.3390/jcm11123418.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.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 from a literature article regarding infective endocarditis (ie) following surgical aortic valve replacement (savr) and transcatheter aortic valve replacement (tavr).All data was retrospectively collected from a single center between january 2013 and december 2020.A total of 120 patients who underwent surgery for ie following savr (n = 98) and tavr (n = 22) were included in the study population.In the tie (ie following tavr) group, 19 patients had been implanted with a non-medtronic transcatheter valve, while the remaining 3 patients were previously implanted with a medtronic corevalve transcatheter valve.No unique device identifier numbers were provided.The tie group was predominantly male with a median age of 77 years.In the tie group, the authors noted pacemaker and atrial fibrillation in table 1 (baseline parameters prior to undergoing surgery for ie).The need for permanent pacemaker implant and the occurrence of atrial fibrillation may have been associated with the tavr valves or the tavr implant procedure.In the tie group, the duration between tavr and onset of ie was a median 1.2 years (0.4 to 2.8 years).Prior to performing surgery for ie, the authors observed the following adverse effects: cerebral emboli, low cardiac output syndrome, decreased left ventricular ejection fraction, paravalvular leakage, aortic stenosis, mild to severe aortic regurgitation, mild to severe mitral regurgitation, mild to severe tricuspid regurgitation, pulmonary hypertension, vegetations, and abscess.In all cases, the tavr valves were explanted and replaced with either a biological or mechanical prosthesis.In the tie group, 2 in-hospital deaths occurred following surgery for ie.No statement was made suggesting a causal or contributory relationship between corevalve and the deaths.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: saha s, et al.Surgery for aortic prosthetic valve endocarditis in the transcatheter era.Journal of clinical medicine.20 22 jun 14;11(12):3418.Doi: 10.3390/jcm11123418.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.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: COREVALVE 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: 15883201
• MDR Text Key: 304508071
• Report Number: 2025587-2022-03347
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male