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

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problems Non specific EKG/ECG Changes (1817); Endocarditis (1834)

Event Date 10/08/2020

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding the impact of aortic root repair or replacement in patients with root endocarditis.All data was retrospectively collected from a series of patients with left-sided endocarditis who underwent cardiac surgery during the active phase of infection from 1997 to 2020 at a single center.The study population consisted of 148 patients with aortic root abscesses who underwent either aortic root repair (n = 85) or aortic root replacement (n = 63).In the aortic root replacement group (predominantly male, mean age 60.9 years), 5 patients received a human homograft, 3 patients received a biointegral conduit, and 55 patients received a medtronic freestyle aortic root bioprosthesis.No unique device identifier numbers were provided.In the aortic root replacement group, 19 peri-operative deaths occurred.Additionally, an unidentified number of patients died during long-term follow-up.The circumstances of the deaths were not disclosed.No statement was made suggesting a causal or contributory relationship between freestyle and the deaths.In the aortic root replacement group, non-death adverse events included: need for extracorporeal membrane oxygenation in the intra- or post-operative period; permanent pacemaker implantation for post-operative atrioventricular heart block (unspecified degree); need for valvular reoperation; and recurrent endocarditis.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: gollmann-tepeköylü c, et al.Impact of aortic root repair or replacement in severe destructive aortic valve endocarditis with paravalvular abscesses on long-term survival.Interactive cardiovascular and thoracic surgery.2022 feb 21;34(3):361-368.Doi: 1 0.1093/icvts/ivab330.Presented at the 34th annual meeting of the european association for cardio-thoracic surgery, barcelona, spain, 8-10 october 2020.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.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: 15381207
• MDR Text Key: 299492943
• Report Number: 2025587-2022-02483
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2022

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?: 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
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/08/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male