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

Model Number 310C27

Device Problems Material Perforation (2205); Insufficient Information (3190)

Patient Problems Endocarditis (1834); No Information (3190)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that two years and six months post implant of this 27mm bioprosthetic mitral valve, it was explanted and replaced with a valve of the same size and model.The reason for replacement is unknown.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the patient's valve was explanted due to a perforated leaflet.It was reported that the perforation was "likely due to endocarditis".No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8117387
• MDR Text Key: 128852956
• Report Number: 2025587-2018-03239
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169594845
• UDI-Public: 00643169594845
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: 310C27
• Device Catalogue Number: 310C27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2018
• Date Device Manufactured: 01/27/2016
• 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
• Patient Age: 75 YR