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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MOSAIC ULTRA AORTIC VALVE
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MEDTRONIC MOSAIC ULTRA AORTIC VALVE Back to Search Results
Catalog Number 305U223
Device Problem Material Perforation (2205)
Patient Problems Adhesion(s) (1695); Aortic Insufficiency (1715); Congestive Heart Failure (1783); Dyspnea (1816)
Event Date 01/20/2016
Event Type  Injury  
Event Description
Pt 3 years status post aortic valve replacement, mitral annuloplasty, coronary bypass grafting x1 performed by dr.(b)(6), the pt did well until recently when he started experiencing exertional shortness of breath and was found to have congestive heart failure and significant prosthetic aortic insufficiency.He underwent workup by his cardiologist, dr.(b)(6), and was referred for a reoperative aortic valve replacement and coronary bypass grafting to the large diagonal vessel.The pt had moderate intrapericardial adhesions.Aorta was free of significant calcification at cross clamp aortotomy and proximal anastomosis sites.Saphenous vein was of excellent size and quality.The prosthetic valve had a perforated leaflet in the right coronary cusp explaining the severe prosthetic aortic insufficiency.
 
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Brand Name
MOSAIC ULTRA AORTIC VALVE
Type of Device
MOSAIC ULTRA AORTIC VALVE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key5396842
MDR Text Key37088175
Report NumberMW5059727
Device Sequence Number1
Product Code LWR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number305U223
Device Lot NumberB031543
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/21/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age74 YR
Patient Weight82
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