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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

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MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE Back to Search Results
Model Number 310C33
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Heart Block (4444)
Event Date 12/18/2018
Event Type  Injury  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Medtronic received information that 13 days post implant of this 33mm mitral bioprosthetic valve, a permanent pacemaker was implanted.The reason for the permanent pacemaker was reported as atrio-ventricular block (avb) 3rd degree, persistent with escape at 25 beats per minute (bpm).It was noted by the surgeon that "conduction disturbance were due to his congenital pathology, partial atrio ventricular canal (cav)".Concomitantly when the valve was implanted they did a partial atrio ventricular canal (cav) closure.No additional adverse patient effects were reported.
 
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Brand Name
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
Type of Device
REPLACEMENT HEART-VALVE
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 Key18960146
MDR Text Key338371644
Report Number2025587-2024-01851
Device Sequence Number1
Product Code DYE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P990064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/21/2023
Device Model Number310C33
Device Catalogue Number310C33
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2024
Initial Date FDA Received03/22/2024
Date Device Manufactured03/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention; Hospitalization;
Patient Age69 YR
Patient SexMale
Patient Weight87 KG
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