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

Model Number 305U

Device Problem Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Unspecified Infection (1930); No Information (3190)

Event Date 03/31/2010

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 this patient has 2 devices listed in the aortic position in our system.Research is being done to determine the location of this patient's devices.No adverse patient effects were reported. .

Manufacturer Narrative

Additional information was received that 9 months post implant of this 21 mm aortic bioprosthetic valve the patient presented with increasing symptoms of congestive heart failure and fever.Blood cultures noted strep viridans.As a result the physician made the decision to explant the device.During explant the physician noted that the valve itself did not appear to have any vegetation present.The valve appeared well seated and healed with no evidence of any issues.A transesophageal echocardiogram (tee) was performed which showed some mild incompetence of the valve.The valve was explanted and replaced with a 23 mm bioprosthetic valve.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC
• 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: 7130204
• MDR Text Key: 95256829
• Report Number: 2025587-2017-02498
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00885074253220
• UDI-Public: 00885074253220
• 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: 01/09/2018

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 Date: 03/05/2014
• Device Model Number: 305U
• Device Catalogue Number: 305U21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/09/2018
• Date Device Manufactured: 03/30/2009
• 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: 57 YR