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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

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EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES Back to Search Results
Model Number 20000ISMCL
Device Problem Malposition of Device (2616)
Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)
Event Date 09/13/2021
Event Type  Injury  
Event Description
Edwards received notification of a pascal in tricuspid position where there was massive tricuspid annular dilatation with malcoaptation, septal leaflet tethering.The clasp device was partially on the leaflets and were removed.
 
Manufacturer Narrative
The event is captured by edwards lifesciences under complaint #: (b)(4).Based on the image evaluation findings this device was also contributory to the event- leading to high residual tr.The device was removed.This mdr is linked to a previous one under mfr report number 2015691-2023-15051 which is for the same patient.Also, this is an initial + final combined mdr report.The complaint for reduced therapeutic efficacy over time / incorrect implant position was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.Based on the imaging evaluation, residual tr post-procedure is semi-quantitatively severe after the implantation of two pascal ace devices with an untreated central valve regurgitation.Possible contributing factors to the high residual tr include procedural related issues and positioning of the ace devices leaving the largest central tr jet untreated.Available information suggests that patient conditions including a large flail segment may have contributed to the reported event.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve, addressing degenerative mitral regurgitation.Therefore, deployment in the tricuspid position is considered off-label.
 
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Brand Name
EDWARDS PASCAL PRECISION
Type of Device
MITRAL VALVE REPAIR DEVICES
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
cassandra cook
1 edwards way
irvine, CA 92614
5743778277
MDR Report Key17777783
MDR Text Key323785523
Report Number2015691-2023-16046
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P220003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/19/2023
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? No
Device Operator Health Professional
Device Expiration Date10/28/2021
Device Model Number20000ISMCL
Device Lot Number63780922
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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