MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; REPLACEMENT HEART-VALVE

Model Number MDT-TISSUE VALVE

Device Problems Degraded (1153); Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001); Central Regurgitation (4068)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Unspecified Infection (1930); Pericardial Effusion (3271); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/18/2023

Event Type  Injury  

Event Description

Literature was reviewed regarding repair of aortic regurgitation in young adults.The study population included 172 patients with a median age of 29 years who were predominantly male.Multiple manufacturer¿s devices were implanted in the study population; 35 patients were implanted with a medtronic freestyle (n=16), mosaic (18), or hancock (n=1) surgical bioprosthetic valve.There were three deaths in the study population during the follow-up period due to ¿valve-related complications¿.The valve manufacturers or models were not specified, and no other details were provided on these deaths.Other deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and these deaths.Among all patients adverse events included: atrial fibrillation, pericardial effusion, complete heart block requiring permanent pacemaker implant, stroke, acute kidney injury, infection, congestive heart failure requiring cardiac resynchronization or implantable cardioverter defibrillator implantation, structural valve dysfunction, infective endocarditis, moderate to severe aortic regurgitation, and patient-prosthesis mismatch.No further information was provided pertaining to medtronic products.

Manufacturer Narrative

Citation: barradas-pires et al.Repair of aortic regurgitation in young adults: sooner rather than later.J am heart assoc.2023 sep 19;12(18):e029251.Doi: 10.1161/jaha.122.029251.Epub 2023 sep 18.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.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: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• 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: 18918382
• MDR Text Key: 337844615
• Report Number: 2025587-2024-01705
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• 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
• Patient Age: 29 YR
• Patient Sex: Male