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

Model Number 5200M32

Device Problems Incomplete Coaptation (2507); Device Dislodged or Dislocated (2923)

Patient Problems Corneal Pannus (1447); Mitral Regurgitation (1964); Tricuspid Regurgitation (2112)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: post-operatively, the body undergoes various phases of the tissue response continuum resulting in the fibrous encapsulation of the implanted annuloplasty ring.Local and systemic factors of the patient may play a role in the wound healing and inflammatory responses to biomaterials and implants.The subject device was not returned for evaluation.The device history record (dhr) review has not been completed.A supplemental report will be filed once the dhr findings are available.In this case, a definitive root cause for early pannus could not be conclusively determined.However, there are no indications of a manufacturing defect.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported via the implant patient registry that a ring model 5200m32 implanted in the mitral position and a ring model 6200t30 implanted in the tricuspid position were explanted after an implant duration of 4 years and 8 months due to severe mitral regurgitation and tricuspid ring dehiscence leading to severe tricuspid regurgitation.A valve model 7300tfx33 and a valve model 6900p33 were implanted in replacement in the mitral and in the tricuspid position respectively.Per the op report received, the mitral prosthetic ring was endothelialized, there was a dehiscence of about 1 cm at the anterior part of the ring.Per the surgeon, this was not probably the cause of the recurrence of the regurgitation.The posterior leaflet was very restricted in its movements.The tricuspid prosthetic ring was dehiscent on a little more than a third of its circumference, at its anterior part.This was most likely the cause of the recurrence of the regurgitation.Discontinuation of cec was performed without hemodynamic problem, with proper functioning of bioprostheses.Per the sales rep's response the explanted devices are not available for return.(b)(4) was opened to capture the ring in the mitral position (b)(4) was opened to capture the ring in the tricuspid position.

Manufacturer Narrative

Post-operatively, the body undergoes various phases of the tissue response continuum resulting in the fibrous encapsulation of the implanted annuloplasty ring.Local and systemic factors of the patient may play a role in the wound healing and inflammatory responses to biomaterials and implants.The subject device was not returned for evaluation.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.In this case, a definitive root cause for early pannus could not be conclusively determined.However, there are no indications of a manufacturing defect.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

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: 10062250
• MDR Text Key: 199900593
• Report Number: 2015691-2020-11871
• 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,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5200M32
• 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: 78 YR