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

Model Number CRS

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Citation: moroni f, et al.Transcatheter aortic bioprosthesis durability: a single-center experience.Cardiovascular revascularization medicine.2022 oct;43:1-6.Doi: 10.1016/j.Carrev.2022.05.011.Epub 2022 may 19.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 an evaluation of transcatheter aortic valve durability at mid-term follow-up.All data was retrospectively collected and analyzed from a single center between november 2007 and december 2014.A total of 408 patients were included in the study population (predominantly female, mean age 80.7 years).Patients were implanted with either a non-medtronic valve type (n = 306) or a medtronic corevalve transcatheter bioprosthetic valve (n = 102).No unique device identifier numbers were provided.In supplemental table 4, the authors described three valve-related deaths that occurred in patients implanted with corevalve.Case 1 (male, 68 years old) had a follow-up of 3,107 days and cause of death was septic shock secondary to prosthetic valve endocarditis (streptococcus gallolyticus), with reported significant regurgitation.Case 2 (male, 85 years old) had a follow-up of 513 days and cause of death was intractable acutely decompensated heart failure in the setting of severe aortic regurgitation due to paravalvular leak.Case 3 (male, 78 years old) had a follow-up of 303 days and cause of death was intractable acutely decompensated heart failure in the setting of severe aortic regurgitation due to paravalvular leak.None of the other deaths mentioned in the article were attributed to medtronic product.Among all 408 patients, the peri-procedural and in-hospital outcomes of transcatheter aortic valve implantation (tavi) included: coronary obstruction; peri-procedural myocardial infarction; acute kidney injury; vascular complication (minor or major); bleeding (minor, major, life-threatening, or disabling); permanent pacemaker implantation; stroke; and significant paravalvular leaks.During a median follow-up of 1,821 days (4.9 years), the following adverse events were observed: structural valve deterioration (elevated gradients and/or moderate-severe intra-prosthetic aortic regurgitation); bioprosthetic valve failure (composite of hemodynamic deterioration, aortic valve reintervention, and valve-related death); second intervention (repeat tavi or surgical replacement); decreased left ventricular ejection fraction; significant paravalvular leaks; and significant mitral regurgitation.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Updated information: section b5: additional information received from the corresponding physician/author stated that aside from the three valve-related corevalve deaths described in supplemental table 4, none of the other deaths were thought to have a corevalve bioprosthesis as a contributory factor.Furthermore, the corresponding physician/author confirmed that five corevalve patients experienced severe structural valve deterioration (svd) of their corevalve bioprosthesis, and the mechanism of svd was increased mean transvalvular gradients in all five cases.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: 15847727
• MDR Text Key: 304171041
• Report Number: 2025587-2022-03283
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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: 11/29/2022
• 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; Disability; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female