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

Model Number MDT-MECH VALVE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Endocarditis (1834); Foreign Body Reaction (1868); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  Injury  

Event Description

Literature was reviewed regarding patient¿prosthesis mismatch in small-size mechanical prostheses. the study data was collected from 1 january 2000 to 31 december 2011.  multiple manufacturer¿s devices were implanted in 416 patients; 52 of those patients were implanted with a medtronic mechanical prosthetic valve.  patients experienced the following adverse events: severe patient-prosthesis mismatch, major paravalvular leak, endocarditis, valve thrombosis with increased transvalvular gradients, and pannus formation.The status of the devices is unknown. no additional adverse patient effects were reported.

Manufacturer Narrative

Citation: feier et al.Patient¿prosthesis mismatch in contemporary small-size mechanical prostheses does not impact survival at 10 years.J cardiovasc dev dis.2022 jan 31;9(2):48.Doi: 10.3390/jcdd9020048.Earliest date of publication used for date of event.Medtronic products referenced: hall (pma# p790018, product code lwq), open pivot (pma# p990046, product code lwq), advantage (not approved).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: 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: 16550751
• MDR Text Key: 311371314
• Report Number: 2025587-2023-00998
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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: 03/01/2023
• 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; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female