• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX23A
Device Problem Gradient Increase (1270)
Patient Problem Injury (2348)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Valve stenosis may be accompanied by an increased gradient across the valve.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including pannus, calcification, support structure deformation (out-of-round configuration), trauma (cardio-pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.It is normal to have a small gradient across a prosthetic valve after implant.If elevated, it may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular aortic stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to calcification or early thrombus formation.In the instance of a bioprosthetic valve in valve implant an increased gradient can be a result of intravalvular regurgitation and is not a result of a valve leaflet malfunction.If mild, these patients will not require intervention and will be followed with serial echocardiography.If significant and results in symptoms, it may require intervention.In this case, there was no allegation or indication a device malfunction contributed to the event.  the cause of the increased gradient cannot be determined with the limited information.However, it is possible that it may be the progression of pre-existing aortic valve disease.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
 
Event Description
As reported, approximately 2 years post transcatheter valve replacement with a 23mm sapien 3 valve in the mitral position, the patient presented with signs of heart failure with gradients of 21mm hg.  the valve was dilated with a non edward¿s balloon and a second 26mm sapien 3 valve was implanted. post dilation was performed, and the patient left the room with normal gradients and only mild paravalvular leak.  the patient is in stable condition post procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Type of Device
PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
renee van dorne
1 edwards way
irvine, CA 92614
9492506385
MDR Report Key11037919
MDR Text Key222354204
Report Number2015691-2020-15077
Device Sequence Number1
Product Code NPU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/09/2020
Device Model Number9600TFX23A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received12/18/2020
Date Device Manufactured08/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-