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 Arrhythmia (1721); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Renal Failure (2041); Post Operative Wound Infection (2446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/12/2021

Event Type  Injury  

Event Description

Medtronic received information via literature regarding one surgeon¿s longitudinal experience with aortic root replacement.All data were collected from a single center between february 1996 and may 2020.The study population included 409 patients who were predominantly male with a median age of 66 years.The population was divided into two cohorts of patients under 65 years of age (younger) and patients over 65 years of age (older).All patients were implanted with a medtronic freestyle porcine aortic root bioprosthesis.No unique device identifier numbers were provided.Among all patients, in-hospital mortality was 4% among the younger cohort and7% in the older cohort.On follow-up, the 1/5/10-year e vent-free survival was 92%/87%/69% in the younger cohort and 88%/73%/43% in the older cohort.No further details were provided on the deaths.There was no statement of causal or contributory relationship between medtronic product and the deaths.Among all patients, adverse events included: bleeding, severe aortic regurgitation, structural valve deterioration and endocarditis, all requiring re-operation or transcatheter aortic valve replacements (tavr); strokes; deep sternal wound infections; arrhythmias and kidney failure requiring dialysis.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: sweeney j.; et al.Aortic root replacement with medtronic freestyle bioprosthesis: 25-year experience.J card surg.2021 n ov;36(11):4038-4042.Doi: 10.1111/jocs.15910.Pmid: 34386993.Epub 2021 aug 12.Earliest date of publication used for date of event.Medtronic products referenced: freestyle (pma# p970031, product code: lwr).Earliest approved product used for product code and pma#.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: 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: 15955979
• MDR Text Key: 305242953
• Report Number: 2025587-2022-03486
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2022
• 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: 11/10/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male