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

Model Number 5200

Device Problems Degraded (1153); Leak/Splash (1354)

Patient Problems Mitral Regurgitation (1964); No Information (3190)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information are in process.If additional information is received a supplemental mdr will be submitted.Without device return or additional information the clinical observation cannot be confirmed and root cause remains indeterminable.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 32mm annuloplasty ring was disabled after an implant duration of three (3) years, six (6) months, fourteen (14) days due to ring failing.A second device, a 29mm transcatheter valve, was implanted in the mitral position using a valve-in-ring procedure.Both devices remain implanted.Patient was reported to be in stable condition.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.There may be cases where a transcatheter valve is placed through a previously placed annuloplasty ring for recurrent regurgitation and/or stenosis.Annuloplasty rings are an adjunct to the valve repair and recurrent regurgitation occurs as a result of progression of disease and is not related to a device malfunction.Based on the information received the cause of the event is likely due to the progression of disease.

Event Description

The reason for valve-in-ring intervention was due to moderately severe to severe eccentric mitral valve regurgitation.The patient tolerated the procedure without complications.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY 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 ; 1 edwards way; ms mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5327978
• MDR Text Key: 34378615
• Report Number: 2015691-2015-03560
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2016
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 43