MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 40017

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Aortic Valve Stenosis (1717); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Thromboembolism (2654); Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  Injury  

Event Description

Literature was reviewed regarding evaluation of two aortic bioprostheses in a two-center study.The study population included 148 patients who were predominantly male with a mean age of 66 years.Two manufacturer¿s devices were implanted in the study population; 74 patients were implanted with a medtronic avalus bioprosthetic valve.Overall mortality occurred with 11 patients, five of which occurred in the avalus group.One high-risk patient died of sepsis and cardiogenic shock with acute renal failure.Three patients with prosthetic endocarditis died following reintervention to treat endocarditis (2) or due to refractory heart failure induced by septic shock (1).Finally, one patient experienced a myocardial infarction due to acute thrombosis of the right coronary ostium, and subsequently underwent aortocoronary bypass with explant and replacement of the avalus bioprosthesis.Eleven hours post-intervention the patient died.No further information was noted pertaining these deaths.Among all patients adverse events included: stenosis, aortic regurgitation, arrhythmia requiring permanent pacemaker implant, endocarditis, major bleeding, thromboembolic event, and moderate to severe patient-prosthesis mismatch.No further information pertaining to medtronic products was noted.

Manufacturer Narrative

Citation: chiariello et al.Two innovative aortic bioprostheses evaluated in the real-world setting: first results from a two-center study.Cardiovasc surg (torino).2023 jun;64(3):338-347.Doi: 10.23736/s0021-9509.23.12534-1.Epub 2023 apr 20.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: AVALUS AORTIC TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 17794326
• MDR Text Key: 323983675
• Report Number: 2025587-2023-03838
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170006
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40017
• Device Catalogue Number: 40017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male