MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL MECHANICAL VALVE; HEART-VALVE, MECHANICAL

Model Number MDT-MECH VALVE

Device Problem Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Non specific EKG/ECG Changes (1817); Hemolytic Anemia (2279); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Citation: onorato em, et al.Case report: challenging treatment of an aorticparavalvular leak: how we avoided interference with mechanical valve function? frontiers in cardiovascular medicine.2022; 9: 839159.Published online 2022 jun 27.Doi: 10.3389/fcvm.2022.839159.Earliest date of publication used for date of event.Medtronic product referenced: ¿mechanical tilting disc aortic prosthetic valve (medtronic starlight 27 mm)¿.Based on this description, this may be referring to the medtronic-hall single-tilting disc mechanical aortic valve (product code lwq, pma# p790018).Therefore, used medtronic-hall device data 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.

Event Description

Medtronic received information from a literature case report regarding a 69-year-old male patient who had undergone surgical aortic valve replacement in 2005 with a 27 mm medtronic mechanical tilting disc aortic valve (serial number not provided).Several years later, the patient was admitted to the hospital for recurrent episodes of congestive heart failure, dyspnea, and hemolytic anemia requiring multiple red blood cells transfusions.After red blood cell transfusions, the clinical and hemodynamic conditions significantly improved each time.Electrocardiogram showed bi-atrial enlargement, left bundle branch block and frequent ventricular ectopic beats.Two-dimensional transthoracic/transesophageal color doppler echocardiography showed severe left ventricle dilatation with ejection fraction of 50% and confirmed the presence of a large 17 x 6 mm crescent-shaped moderate-to-severe aortic paravalvular leak (pvl) located at non coronary cusp 9-12 o¿clock.Subsequently, the patient underwent a transcatheter pvl closure procedure in which two pvl closure devices had to be implanted to address the pvl.The procedure was complicated by transient interference of the second pvl closure device with the function of the mechanical aortic valve.However, the issue was resolved with correct manipulation, orientation, and downsizing of the second closure device implanted.At three-month and thirteen-month follow-up, the patient showed relevant clinical improvement and good quality of life.No further hospitalizations or blood transfusions were needed.Two-dimensional transthoracic color doppler confirmed stable position of the two pvl closure devices with trace residual leak.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL MECHANICAL VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 15686170
• MDR Text Key: 302564136
• Report Number: 2025587-2022-03002
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P790018
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MDT-MECH VALVE
• Device Catalogue Number: MDT-MECH VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• 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: 69 YR
• Patient Sex: Male