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

Model Number MDT-TRANS VALVE

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Transient Ischemic Attack (2109); Rupture (2208); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

Citation: costa g, et al.Real-world multiple comparison of transcatheter aortic valves: insights from the multicenter observant ii study.Circulation: cardiovascular interventions.2022 dec;15(12):e012294.Doi: 10.1161/circinterventions.122.012294.Epub 2022 dec 9.Earliest date of publication used for date of event.Medtronic products referenced: evolut r (pma# p130021, product code npt), evolut pro (pma# p130021, product code npt).Earliest approved product used for product code and pma#.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 a comparison of the most used transcatheter aortic valve implantation (tavi) platforms.A total of 2,728 patients were included in the study population.Tavi platforms used in the study were as follows: medtronic evolut r (n = 1,125), medtronic evolut pro (n = 337), edwards sapien 3 (n = 768), boston scientific acurate neo (n = 290), and abbott portico (n = 208).Kaplan-meier estimates were used to show the rates of one-year all-cause death among the evolut r/pro patients.The authors did not present any evidence to suggest that the evolut r/pro valves or their function contributed to the deaths.Adverse events observed among all evolut r/pro patients included: valve migration during the procedure, aborted procedure for unspecified reason, more than one transcatheter valve implanted, emergent valve-in-valve implantation, coronary ostiaobstruction, myocardial infarction, annulus rupture, interventricular defect, cardiac tamponade, conversion to surgery, cardiogenic shock, unspecified vascular injury (major or minor), permanent pacemaker implantation, post-procedural left bundle branch block, post-procedural atrial fibrillation, stroke (disabling or non-disabling), transient ischemic attack, bleeding (minor, major, or life-threatening), acute kidney injury, paravalvular regurgitation (mild to severe), and re-hospitalization for heart failure.No additional adverse patient effects or product performance issues were noted.

• Brand Name: MEDTRONIC TRANSCATHETER 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: 16309397
• MDR Text Key: 308915025
• Report Number: 2025587-2023-00422
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• 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): Disability; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female