MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 310

Device Problems Thickening of Material (4056); Device Stenosis (4066)

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965)

Event Date 01/03/2024

Event Type  Injury  

Event Description

Literature was reviewed regarding a patient who underwent implant of a medtronic 27-mm mosaic bioprosthetic valve in the mitral position 17 years prior.  more recently the patient presented with nyha functional class iii symptoms.  transthoracic echocardiography revealed mitral stenosis and computed tomography showed evidence of inflow pannus and leaflet thickening.  subsequently the patient underwent a procedure in which a non-medtronic valve was to be implanted valve-in-valve inside the mosaic valve.  the first attempted non-medtronic valve was displaced by the pannus and migrated out of the desired position.  a second non-medtronic valve was successfully deployed in a more atrial position to prevent further movement of the first attempted valve.  following balloon dilatation transesophageal echocardiography confirmed a good hemodynamic measurements.  no further information was provided pertaining to medtronic products.

Manufacturer Narrative

Citation: jelisejevas et al.Transcatheter mitral valve-in-valve replacement in the presence of pannus: a word of caution.Jacc card iovasc interv.2024 feb 26;17(4):574-576.Doi: 10.1016/j.Jcin.2023.11.024.Epub 2024 jan 3.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.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: MOSAIC MITRAL BIOPROSTHETIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 18849311
• MDR Text Key: 337034089
• Report Number: 2025587-2024-01430
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P990064
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310
• Device Catalogue Number: 310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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; Hospitalization; Life Threatening