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

Model Number 995

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Cardiac Tamponade (2226); Post Operative Wound Infection (2446); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/25/2020

Event Type  Injury  

Event Description

Medtronic received information via literature regarding long-term outcomes using stentless porcine aortic root bioprostheses for right ventricular outflow tract reconstruction (rvotr).All data were collected from a single center between april 2000 and october 2019.The study population included 135 patients who were predominantly male with a mean age of 32 years.All patients were implanted with a medtronic freestyle aortic root bioprosthesis in the pulmonary position.No unique device identifier numbers were provided.Among all patients, nine deaths occurred, with three patients dying from multisystem organ failure within 30 days of rvotr.Within the first year post-rvotr, three patients died from hepatic dysfunction and metastatic carcinoid tumors.Three late deaths occurring 5-11 years post-rvotr were due to endocarditis and pneumonia.There was no statement of causal or contributory relationship between medtronic product and the deaths.Based on the available information medtronic product was not associated with the deaths.Among all patients, adverse events included: need for re-operation for mediastinal hemorrhage and cardiac tamponade; pericardial and pleural effusions; mediastinal infections; new-onset atrial fibrillation/flutter; right heart failure.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: kasten m.; et al.Two decades using stentless porcine aortic root in right ventricular outflow tract reconstruction.Ann thorac surg.2021 sep;112(3):816-823.Doi: 10.1016/j.Athoracsur.2020.06.117.Pmid: 32946841.Epub 2020 sep 16.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: 15525964
• MDR Text Key: 301007129
• Report Number: 2025587-2022-02715
• 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: 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• 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: 09/02/2022
• 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
• Treatment: UNKNOWN IPG
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male