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

Model Number	305C2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Pannus (1447); Aortic Valve Stenosis (1717)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, the sewing ring was damaged along the right and non coronary cusps.Damage occurred likely during explant.The valve stent posts appeared deflected.All leaflets were in the closed position with the left cusp free margin on the same plane as the coaptive ridge of the right cusp.All leaflets were slightly stiff but flexible except where pannus extended on the inflow.It appeared that the nodule of aranti on the lunula of the left cusp was torn off.No loose tissue was returned with the valve.All commissures were intact.Pannus on the inflow lined the tissue and base stitching adjacent to all cusps, extending over the inflow margin of attachment, and 1 to 5 mm onto all cusps showing a reduced inflow orifice area.An unknown amount of pannus appears to have been removed on the inflow and outflow during explant.Radiography showed no evidence of calcification on the valve leaflets.Conclusion: the device was returned for analysis.Visual inspection was performed on the returned device.The pannus overgrowth on the inflow appears to have extended several millimeters out onto the leaflet which would have significantly impaired the leaflet mobility.The impairment of leaflet mobility may have led to the stenosis.Pannus overgrowth is associated with surgical valve replacement due to patient interaction and/or healing response with the surgical valve.Pannus overgrowth has been an inherent risk of surgical valve replacement.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 5 years and 11 months post implant of this bioprosthetic valve, it was explanted and replaced due to stenosis.An aortic aneurysm repair was also performed during this intervention.No other adverse patient effects were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6871073
• Report Number: 2025587-2017-01618
• Device Sequence Number: 19138510
• Product Code: LWR
• UDI-Device Identifier: 00613994760692
• UDI-Public: 00613994760692
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

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: 09/08/2015
• Device Model Number: 305C2
• Device Catalogue Number: 305C227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/15/2017
• 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: 53 YR