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

Model Number 310

Device Problems Partial Blockage (1065); Degraded (1153); Gradient Increase (1270); Reflux within Device (1522); Incomplete Coaptation (2507)

Patient Problems Mitral Valve Stenosis (1965); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Citation: gonzales p.; et al.Preemptive alcohol septal ablation prior to valve-in-valve transcatheter mitral valve replacement with bioprosthetic balloon fracture.Jacc case rep.2021 mar 17;3(3):366-369.Doi: 10.1016/j.Jaccas.2020.12.021.Pmid: (b)(4).Ecollection 2021 mar.Earliest date of publication used for date of event.Medtronic products referenced: mosaic (pma# p990064, product code: dye).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.

Event Description

Medtronic received information via literature regarding a 78-year-old female patient with a past medical history of pulmonary hypertension, atrial fibrillation, sick sinus syndrome status-post permanent pacemaker, and a remote history of a stroke.She underwent surgical implant of a 25-mm medtronic mosaic bioprosthetic mitral valve in 2004 (unique device identifier numbers not provided).Mild right ventricular outflow tract (rvot) obstruction occurred after the implantation, due to physical interaction between the valve edge and basal septum.In 2019, the patient was noted to have refractory heart failure symptoms and was hospitalized.Transthoracic and transesophageal echocardiography (tte/tee) revealed severe structural degeneration of the mosaic valve with thickened leaflets, causing moderate mitral stenosis with severe mitral regurgitation, severe elevated transvalvular gradients and right ventricular dilation/failure.The patient underwent septal alcohol ablation to eliminate septal hypertrophy and reduce the chances of further rvot obstruction after intervention.Approximately 5 weeks post-ablation, the patient underwent mitral valve balloon fracturing with transcatheter mitral valve replacement (tmvr) using a 23-mm non-medtronic bioprosthetic valve.The patient was discharged two days later with complete resolution of symptoms and normal transvalvular gradients on 1-month follow-up.No additional adverse patient effects or product performance issues were reported.

• 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: 15090295
• MDR Text Key: 296459531
• Report Number: 2025587-2022-02085
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 310
• Device Catalogue Number: 310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• 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
• Treatment: UNKNOWN IPG.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female