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

Model Number 6200T34

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.A manufacturing related issues was not identified.A definitive root cause cannot be determined.Of note, the surgeon downsize the ring from a 34 mm to a 30 mm ring.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.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information a 34 mm tricuspid ring was explanted after an implant duration of two years and one month due to tricuspid regurgitation.Per obtain information, the tricuspid valve had several areas of dehiscence around the circumference between the annulus and the ring.The 34 mm annuloplasty ring was removed along with its sutures and the annulus was resized with a smaller 30 mm tricuspid ring.Postoperatively, the patient was weaned off from bypass without difficulty and hemodynamically stable.The patient tolerated to procedure well without complications and transferred to the cvicu in stable condition.

• Brand Name: CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irivne CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7125002
• MDR Text Key: 95175990
• Report Number: 2015691-2017-04348
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Model Number: 6200T34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Date Device Manufactured: 02/26/2015
• 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: 40 YR