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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN MITROFLOW #23; AORTIC VALVE REPLACEMENT
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SORIN MITROFLOW #23; AORTIC VALVE REPLACEMENT Back to Search Results
Catalog Number LXA23
Device Problems Degraded (1153); Gradient Increase (1270); Occlusion Within Device (1423)
Patient Problems Aortic Regurgitation (1716); Congestive Heart Failure (1783); Thrombosis (2100); Test Result (2695)
Event Date 01/09/2015
Event Type  Injury  
Event Description
Patient presented on (b)(6) 2015 with acute decompensated left sided chf and suspected early deterioration of her aortic valve prosthesis.Echo performed on (b)(6) 2014 showed a new and severe gradient across her mitroflow aortic valve and the patient was sent to (b)(6) per her request.Evaluation at (b)(6) on (b)(6) 2014 suggests there may be some thrombus on the valve, anticoagulation started.(b)(6) reported they had seen few cases of thrombosis on bioprosthetic tissue valves which have responded to anticoagulation.Patient returned to (b)(6) on (b)(6) 2015 with acute decompensated left sided chf and suspected early deterioration of her aortic valve prosthesis.Patient had another tee on (b)(6) 2015 which showed no significant gradient across her new mechanical aortic valve and a mild perivalvular aortic regurgitation.Patient on anticoagulation and is followed in the heart failure and anticoagulation clinic at the heart doctors.
 
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Brand Name
MITROFLOW #23
Type of Device
AORTIC VALVE REPLACEMENT
Manufacturer (Section D)
SORIN
MDR Report Key4739550
MDR Text Key16852463
Report NumberMW5042378
Device Sequence Number1
Product Code LWR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberLXA23
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Disability;
Patient Age62 YR
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