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

Model Number 445026MM

Device Problems Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Scarring (2061)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Post-operatively, the body undergoes various phases of the tissue response continuum resulting in the fibrous encapsulation of the ring.Local and systemic factors of the patient may play a role in the wound healing and inflammatory responses to biomaterials and implants.Only cases in which the patient¿s response to the ring requires explantation within 5 years will be reportable.In this case, the ring was explanted after an implanted of 3 years and 6 months due to extensive scarring and pannus formation with severe mitral stenosis and moderate mitral regurgitation.Host tissue 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.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.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.There was no indication or allegation of product malfunction, therefore the device was not requested for return.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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

It was reported that a 26mm annuloplasty mitral ring, implanted for 3 years and 6 months, had an explant procedure due to extensive scarring and pannus formation with severe mitral stenosis and moderate mitral regurgitation.A 27mm replacement mitral valve was implanted in the patient.The patient also underwent tricuspid valve repair with a 32mm edwards annuloplasty ring.The patient was transported to the icu in stable condition.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8938066
• MDR Text Key: 156425537
• Report Number: 2015691-2019-03210
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Model Number: 445026MM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR