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

Model Number 995

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Dyspnea (1816); Fatigue (1849); Foreign Body Reaction (1868); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Citation: wilder t., et al.Rapid-deployment aortic valve replacement after aortic root replacement: a safe alternative to redo root replacement.J card surg.2020 jan;35(1):222-225.Doi: 10.1111/jocs.14278.Pmid: 31609491.Epub 2019 oct 14.Earliest date of publish used for date of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a case series using rapid-deployment aortic valve prostheses to avoid surgical valve replacement.All data were collected from a single center.The study population included three patients (two female/one male, mean age (b)(6)), two of whom had previously undergone surgical aortic root replacement using medtronic freestyle aortic root conduits (unique device identifier numbers not provided).For the two medtronic freestyle patients, adverse events included: need for transcatheter aortic valve replacement due to conduit degeneration.The conduits showed moderate-severe annular/valve leaflet calcification, large sub-annular fibrous panni and high aortic transvalvular gradients per echocardiography.Patients experienced moderate-severe aortic stenosis/insufficiency with symptoms of heart failure including progressive fatigue and shortness of breath.The patients were hospitalized and underwent aortic valve replacement.The calcified freestyle leaflet valves were excised, annular debridement was performed and then the freestyle conduits were serially dilated.Non-medtronic transcatheter valves were then seated within the conduits.Based on the available information medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 12306952
• MDR Text Key: 265997572
• Report Number: 2025587-2021-02518
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/11/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 64 YR