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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II RING ANNULOPLASTY RING

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EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II RING ANNULOPLASTY RING Back to Search Results
Model Number 5200
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Mitral Valve Stenosis (1965)
Event Date 02/29/2016
Event Type  Injury  
Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation as it was reported to be unavailable. However, the device history record (dhr) was reviewed and showed that this device met all manufacturing specifications for product release prior to distribution. No issues were identified that would have impacted this event. Prosthesis-patient mismatch (ppm) is present when the effective orifice area of the heart valve is too small in relation to body size after implant of a bioprosthetic device (valve or annuloplasty ring). A smaller than expected effective orifice area (eoa) in relation to the patient's body surface area (bsa) will result in higher transvalvular gradients. Ppm is associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival. Ppm can be prevented by using an appropriate sized device or prospective strategy at time of initial implant. In this case, it was reported that the ring was too small for this patient which resulted in patient prosthesis mismatch and led to the mitral stenosis. Stenosis, which develops progressively over time, can be due to a number of issues. Additionally, there can be a number of potential known and unknown patient related contributing factors. Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these. Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation. Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis. As the device was not returned to edwards for analysis, the root cause for the event could not be conclusively determined. However, it is likely that patient related factors and procedural factors may have contributed to the event. The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device. No capa is applicable to this case; however, edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

 
Event Description

Edwards received information that a patient with a 24mm annuloplasty ring underwent an explant surgery after an implant duration of three (3) years, eight (8) months, and seven (7) days. The surgeon reported that the ring was too small for this patient which resulted in patient prosthesis mismatch and led to mitral stenosis. The explanted ring was replaced with a 25mm pericardial mitral valve. It was reported that there was no allegation of a device malfunction. However, the ring was too small for the patient's body surface area as the patient was considered to be quite large. The patient was discharged on post-operative day seven (7). No additional details were made available and the explanted device is not available for return.

 
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Brand NameCARPENTIER-EDWARDS PHYSIO II RING
Type of DeviceANNULOPLASTY RING
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
neil landry
one edwards way
mle-8
irvine, CA 92614
9492502289
MDR Report Key5533634
MDR Text Key41407580
Report Number2015691-2016-00991
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/14/2016
Device MODEL Number5200
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/22/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/29/2016 Patient Sequence Number: 1
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