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

Model Number 995

Device Problem Degraded (1153)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067)

Event Date 05/04/2019

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding the influence of an aortic root abscess on perioperative outcomes and long-term survival in patients with active endocarditis treated with surgical aortic valve or root replacement.All data was collected from a single center between 1996 and october 2019.Of the 336 patients with active endocarditis included in the study population (predominantly male, median age 55 years), 176 underwent aortic root replacement with a medtronic freestyle bioprosthesis (root abscess = 119, no root abscess = 57).No unique device identifier numbers were provided.Among all 336 patients, the 10-year survival rates were 41% and 43% for patients with root abscess and no root abscess, respectively.No statement was made suggesting a causal or contributory relationship between freestyle and any of the deaths.Among all 336 patients, post-operative non-death adverse events included: red blood cell transfusion (1 to 7 units); reoperation for bleeding; sternal dehiscence; sepsis; stroke; cardiac arrest; permanent pacemaker or implantable cardioverter defibrillator implantation; atrial fibrillation; and reoperation for structural valve deterioration or reinfection.Freestyle may have been associated with these adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: yang b, et al.Root abscess in the setting of infectious endocarditis: short- and long-term outcomes.J thorac cardiovasc surg.2021 oct;162(4):1049-1059.E1.Doi: 10.1016/j.Jtcvs.2019.12.140.Epub 2020 apr 13.Read at the 99th annual meeting of the american association for thoracic surgery, toronto, ontario, canada, may 4-7, 2019.Earliest date of presentation 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.

• 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: 13551182
• MDR Text Key: 289874905
• Report Number: 2025587-2022-00476
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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: 01/19/2022
• 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; Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male