MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP MITRAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500DM

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Angina (1710); Stroke/CVA (1770); Dyspnea (1816); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

Citation: sari m, et al.Characteristic localization patterns of thrombus on various brands of bileafet mitral mechanical heart valves as assessed by three dimensional transesophageal echocardiography and their relationship with thromboembolism.The international journal of cardiovascular imaging.2021 sep;37(9):2691-2705.Doi: 10.1007/s10554-021-02234-y.Epub 2021 apr 9.Earliest date of publish 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.

Event Description

Medtronic received information from a literature article regarding the localization patterns of thrombus on various brands of bileafet mechanical mitral valves.All data was retrospectively collected from a single center between january 2009 and december 2019.The study population included 265 patients with documented mechanical mitral valve thrombosis.Patients were previously implanted with either a non-medtronic mechanical mitral valve (n = 236) or a medtronic ats open pivot mechanical mitral valve (n = 29).No unique device identifier numbers were provided.The ats open pivot group was predominantly female with a mean age of 45.6 years.In the ats open pivot group, the duration between valve implant and diagnosis of mechanical mitral valve thrombosis ranged between 0.5 and 5 years.In the ats open pivot group, symptoms and thromboembolic events on admission included: unspecified cerebrovascular events, coronary embolism, dyspnea, angina, and heart failure.Echocardiographic characteristics of ats open pivot valve thrombosis were as follows: elevated transmitral gradients, non-obstructive or obstructive thrombus (localized near the left atrial appendage or left atrium), non-obstructive pannus, and moderate to severe paravalvular leak.No additional adverse patient effects or product performance issues were reported.

• Brand Name: OPEN PIVOT AP MITRAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15331429
• MDR Text Key: 299038419
• Report Number: 3008592544-2022-00048
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P990046
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500DM
• Device Catalogue Number: 500DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• 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; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female