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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD REGENT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL CATD REGENT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number CVD0045
Device Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported through a research article identifying an unknown sized regent valve that was implanted in 2013 that may be related to a replacement procedure with another regent valve due to recurrence of aortic stenosis, suspected to be caused by pannus formation.Post-procedurally, the patient was on a ventilator for five days due to delayed arousal and respiratory failure.The patient was discharged about two months following the procedure.During a follow up visit, no bleeding or skin lesions were observed on the patient's skin area where the libre sensor is attached.Specific patient information is documented as unknown.Details are listed in the attached article, titled "use of flash glucose monitoring during perioperative period of cardiac surgery in a patient with type 1 diabetes mellitus".
 
Event Description
It was reported through a research article identifying an unknown sized regent valve that was implanted in 2013 that may be related to a replacement procedure with another regent valve due to recurrence of aortic stenosis, suspected to be caused by pannus formation.Post-procedurally, the patient was on a ventilator for five days due to delayed arousal and respiratory failure.The patient was discharged about two months following the procedure.During a follow up visit, no bleeding or skin lesions were observed on the patient's skin area where the libre sensor is attached.Specific patient information is documented as unknown.Details are listed in the attached article, titled "use of flash glucose monitoring during perioperative period of cardiac surgery in a patient with type 1 diabetes mellitus".
 
Manufacturer Narrative
An event of replacement of a regent valve due to recurrent aortic stenosis, possibly caused by pannus was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
REGENT MECHANICAL HEART VALVE
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL CATD
4 robbins drive
westford MA 01886
MDR Report Key9144960
MDR Text Key161672519
Report Number2648612-2019-00078
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P810002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCVD0045
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
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