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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MOSAIC ULTRA; HEART-VALVE, NON-ALLOGRAFT TISSUE
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MEDTRONIC, INC. MOSAIC ULTRA; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number 305U225
Device Problem Gradient Increase (1270)
Patient Problem Aortic Valve Stenosis (1717)
Event Date 08/02/2017
Event Type  malfunction  
Event Description
Patient had a cabg and aortic valve replacement in the spring.A medtronic mosaic ultra 305 cinch ii aortic valve catalog#: 305u255,size 25 m, implanted at that time.Identified aortic stenosis with high flow gradient.Aortic valve left in, transcatheter aortic valve replacement (tavr) done inside the bio-prosthetic valve approximately 5 months later.Patient discharged in stable condition manufacturer response for mosaic ultra 305 cinch ii aortic valve, (brand not provided) (per site reporter): vendor requesting return of device.
 
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Brand Name
MOSAIC ULTRA
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
MEDTRONIC, INC.
1851 east deere ave.
santa ana CA 92705
MDR Report Key7134309
MDR Text Key95376903
Report Number7134309
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 12/08/2017,12/15/2017
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 No Information
Device Expiration Date09/07/2020
Device Model Number305U225
Device Catalogue Number305U225
Other Device ID NumberSIZE 25MM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/08/2017
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer12/08/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS; NO
Patient Age74 YR
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