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

Model Number	310C29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Mitral Regurgitation (1964)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that 8 years 1 month post implant of this 29mm mitral bioprosthetic valve, it was explanted and replaced with a 31mm mitral bioprosthetic valve due to regurgitation and recent staph aureus endocarditis.The patient had developed shortness of breath and lower extremity edema and was placed on antibiotics.The patient had a murmur that had become more pronounced and demonstrated significant prosthetic valve mitral regurgitation, which required a mitral valve replacement.The valve was sent to the hospital lab for cultures no anaerobes were isolated and no growth resulted.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the intraoperative transesophageal echocardiogram (tee) showed the patient had severe mitral regurgitation.Added patient weight.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7822945
• Report Number: 2025587-2018-02262
• Device Sequence Number: 1574143
• Product Code: LWR
• UDI-Device Identifier: 00613994688927
• UDI-Public: 00613994688927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2015
• Device Model Number: 310C29
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 44