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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE
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CORCYM CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE Back to Search Results
Model Number TBD
Device Problem Insufficient Information (3190)
Patient Problem Thrombocytopenia (4431)
Event Type  Injury  
Event Description
Received information from the field about a perceval plus (unknown model #, serial #) that was implanted, (unknown date), and the patient having profound thrombocytopenia on day one or two post op.No further information is provided about the device functionality at the time of the event, patient impact, nor any treatment provided.
 
Event Description
Received information from the field about a perceval plus (unknown model #, serial #) that was implanted, (unknown date), and the patient having profound thrombocytopenia on day one or two post op.No further information is provided about the device functionality at the time of the event, patient impact, nor any treatment provided.
 
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Brand Name
PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
Type of Device
TISSUE HEART VALVE
Manufacturer (Section D)
CORCYM CANADA CORP.
5005 north fraser way
burnaby, bc V5J 5 M1
CA  V5J 5M1
MDR Report Key13131038
MDR Text Key285990101
Report Number3019892983-2021-01059
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/04/2021,12/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTBD
Device Catalogue NumberTBD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/04/2021
Event Location Hospital
Date Report to Manufacturer12/04/2021
Date Manufacturer Received12/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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