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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES NOVAFLEX+ DELIVERY SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
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EDWARDS LIFESCIENCES NOVAFLEX+ DELIVERY SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9355FS23A
Device Problem Failure to Deliver (2338)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2020
Event Type  Injury  
Manufacturer Narrative
Investigation is ongoing.
 
Event Description
As reported, during a tvr in the pulmonic position with a 23mm sapien xt valve, the patient had a smaller, stiffer anatomy and deploying the valve into the homograft was unsuccessful.  attempts to remove the xt valve and novaflex+ delivery system from the patient were also unsuccessful so the valve was deployed in the lower ivc and a covered stent was placed.  the patient is planned for a surgical pulmonic valve replacement.
 
Manufacturer Narrative
It was found that this event was previously reported by edwards lifesciences.The investigation of the event will remain under mdr:2015691-2020-10910.
 
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Brand Name
NOVAFLEX+ DELIVERY SYSTEM
Type of Device
PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
MDR Report Key9855760
MDR Text Key190953669
Report Number2015691-2020-11022
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
PMA/PMN Number
P130009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9355FS23A
Was Device Available for Evaluation? No
Date Manufacturer Received04/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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