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

Model Number 995

Device Problems Degraded (1153); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

Citation: bittira et al.Intermediate-term outcomes following a case series of reoperations for medtronic freestyle stentless aortic valves.Cjc open.2023 aug 29;5(11):793-797.Doi: 10.1016/j.Cjco.2023.08.008.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.Select patient information cannot be included in regulatory report due to regional privacy regulations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Literature was reviewed regarding intermediate-term outcomes following a case series of reoperations for medtronic freestyle stentless aortic valves.The study population included 24 patients, all of whom were implanted with a medtronic freestyle aortic bioprosthetic valve.One in-hospital death occurred with patient who presented with endocarditis involving the freestyle valve.  the valve was explanted along with repair of a ventricular septal defect, reconstruction of the left ventricular outflow tract, and coronary artery bypass grafting to the left anterior descending artery. the post-operative course included a significantly lengthy cardiopulmonary bypass run with coagulopathy and left ventricular dysfunction requiring mediastinal re-exploration twice.The patient subsequently died of multi-system organ failure five days post-operative. other deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths for these events.  adverse events included: aortic insufficiency, leaflet tear, endocarditis, structural valve dysfunction, bleeding complication requir ing reoperation, acute kidney injury, and reoperation for valve explant.  no further information was provided pertaining to medtronic products.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18975220
• MDR Text Key: 338556906
• Report Number: 2025587-2024-01887
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• 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