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 Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Hematoma (1884); Hemorrhage/Bleeding (1888); Thromboembolism (2654); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)

Event Date 05/30/2022

Event Type  Injury  

Event Description

Literature was reviewed regarding the long-term outcomes of mechanical mitral valve replacement.Medtronic ats (n = 35), non-medtronic (n = 483), and unknown (n = 65) mechanical mitral valves were used in the study.The median clinical follow-up duration was 13.3 years (range of 7.4 to 19.6 years).The authors observed in-hospital, late, and valve-related deaths.Causes of in-hospital death included: low output syndrome, multi-organ failure, intestinal ischemia, and other/unspecified causes.Thromboembolism-related deaths, intracranial hemorrhage-related deaths, and major paravalvular leak-related deaths were also observed.Other adverse events that occurred were described as follows: thromboembolism (minor or major stroke, limb embolism, valve thrombosis, and left atrial thrombus); atrial fibrillation; intracranial hemorrhage (subdural hematoma, intracerebellar hemorrhage, chronic subdural hematoma, traumatic subarachnoid hemorrhage, subarachnoid hemorrhage, and acute epidural hematoma); gastrointestinal bleeding; increased transmitral mean pressure gradient; reoperation for major paravalvular leak (repeat mitral valve replacement or leak closure); and cardiac reoperation.Reasons for cardiac reoperation comprised: mitral paravalvular leak, aortic valve etiology, mitral valve thrombosis, mit ral prosthetic valve endocarditis, and left atrial thrombus.No additional adverse patient effects were noted.

Manufacturer Narrative

Citation: uchino g, murakami h, mukohara n, tanaka h, nomura y, miyahara s et al.Very-long-term outcomes of mechanical valves in mitral position focusing on valve-related complications.Interact cardiovasc thorac surg 2022; doi:10.1093/icvts/ivac146.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.Select patient information cannot be included in regulatory report due to regional privacy regulations.The death report pertaining to this literature article was submitted in regulatory report number 3008592544-2023-00047.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

Additional information received from the corresponding physician/author stated that medtronic ats valves did not cause or contribute to any of the observed deaths or non-death adverse events.The physician/author also stated that because the article did not focus on the causal relationship between the devices used and the adverse events, there is no data showing that there is a causal relationship between them.

Manufacturer Narrative

Updated information: section b5: description of event.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.

• 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: 16801664
• MDR Text Key: 313902719
• Report Number: 3008592544-2023-00048
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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: 06/08/2023
• 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; Life Threatening