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

Model Number 40017

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Citation: tadokoro n, et al.Comparison of safety and haemodynamic performance between the avalus¿ stented aortic valve bioprosthesis and magna¿ valve in japanese patients.Gen thorac cardiovasc surg.2021 jul;69(7):1060-1069.Doi: 10.1007/s11748-020-01566-1.Epub 2021 jan 5.Earliest date of publish 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.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 safety and hemodynamic performance between the avalus and magna surgical aortic valves.All data was retrospectively collected from a single center between april 2012 and march 2020.Of the 468 patients included in the study population, 87 patients (predominantly male, median age 73 years) underwent surgical aortic valve replacement with the medtronic avalus.No unique device identifier numbers were provided.Among all avalus patients, adverse events that occurred between valve implant and hospital discharge included: permanent pacemaker implantation for sick sinus syndrome (one case); and minor ischemic cerebrovascular accident with full recovery (one case).Adverse events that occurred within one-year after valve implant included: mild paravalvular leak (three cases); severe patient-prosthesis mismatch (three cases); and congestive heart failure related to atrial fibrillation requiring in-hospital treatment (one case).No additional adverse patient effects or product performance issues were reported.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12328905
• MDR Text Key: 266867958
• Report Number: 2025587-2021-02565
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: 07/21/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR