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

Model Number 310C

Device Problems Occlusion Within Device (1423); Structural Problem (2506)

Patient Problems Host-Tissue Reaction (1297); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 11/01/2017

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 7 years 4 months post implant of this mitral bioprosthetic valve, the valve was explanted due to stenosis and regurgitation.Upon explant, it was noted that both the inflow and outflow were covered in pannus and one leaflet was perforated.The physician reported that the patient experienced a ¿massive inflammatory reaction to the valve¿ the valve was explanted and replaced.There were no additional adverse patient effects reported.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7045660
• MDR Text Key: 92525640
• Report Number: 2025587-2017-02202
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00885074247878
• UDI-Public: 00885074247878
• 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
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2014
• Device Model Number: 310C
• Device Catalogue Number: 310C31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Date Device Manufactured: 02/26/2009
• 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: 68 YR
• Patient Weight: 102