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

Model Number 4450

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ring dehiscence may occur early or late.When it occurs in the late post-operative period, it is typically a result of successive dilatation of cardiac structures that result from progression of disease.In this case, although there have been attempts to receive further information regarding the device and event, no additional details were provided and the explanted device was not returned to edwards for analysis.At this time, edwards is unable to conclusively determine the root cause for this event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.If further information becomes available, a follow-up report will be submitted.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.In this case, edwards received information that this 30mm annuloplasty ring was explanted after two (2) years, seven (7) months due to mitral regurgitation, secondary to partial dehiscence.This was replaced with a 31mm pericardial bioprosthesis and no additional details were provided.

Manufacturer Narrative

Device evaluation summary - x-ray demonstrated ring intact.Heavy host tissue was observed, and sutures remained attached around the ring.The reported clinical observation cannot be confirmed through device evaluation.Host tissue was found on the ring.Host tissue/pannus growth is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Literature defines pannus as a type of scarring and tissue ingrowth.It is not currently possible to predict the occurrence and severity for any given patient with a bioprosthetic heart valve.A certain degree of host tissue growth is expected.However, abnormal or severe pannus growth can eventually affect the function of the valve.According to literature, pannus typically occurs between 12 months to 5 years.Pannus occurring prior to 12 months is rare and suggests patient factors may have played a significant role.Since the mechanism of host tissue growth in bioprosthetic heart valves is still not fully understood, the root cause for the host tissue growth for this particular valve cannot be determined at this time.

Manufacturer Narrative

Additional manufacturer narrative: a manufacturing related issue was not identified.The root cause of the regurgitation was partial ring dehiscence.It is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.There was no objective evidence of a manufacturing or design defect that caused the ring to not function as intended.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.Edwards adequately addresses potential causes of failure and the associated hazards.Potential cause of failure is progression of disease, deterioration of tissue or undersized ring used.The complaint trend was assessed and it was found to be in control.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems.

• Brand Name: CARPENTIER-EDWARDS PHYSIO 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: t&d 2nd floor, office t223; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5890764
• MDR Text Key: 52609947
• Report Number: 2015691-2016-02567
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926138
• 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,Followup
• Report Date: 07/27/2016

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 Date: 05/06/2018
• Device Model Number: 4450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2016; 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2013
• 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; Required Intervention
• Patient Age: 69 YR