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

Model Number 5200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Regurgitation (2259); Stenosis (2263)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.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.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.A manufacturing related issue was not identified.A definitive root cause could not be determined; however, it is likely that patient related factors contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported via the implant patient registry that a 28mm mitral ring, implanted for two (2) years and four (4) months, was explanted due to fibrous growth, severe recurrent mitral regurgitation, and moderate stenosis.The explanted device was replaced with a 27mm bioprosthetic valve.Patient was taken to icu in satisfactory condition.Per medical records, the patient was found to have recurrent mitral regurgitation with a likely broken commissural suture, and moderate mitral stenosis with a lot of fibrinous tissue around the ring.The 28mm mitral ring was removed.After debridement, a 27mm bioprosthetic valve was implanted.Patient was weaned from cpb.Biventricular function was normal and valve functioned normally.There was good leaflet motion and no paravalvular leak.Patient was taken to icu in satisfactory condition.

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9010508
• MDR Text Key: 158126028
• Report Number: 2015691-2019-03409
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 5200
• 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): Required Intervention
• Patient Age: 57 YR