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

Model Number 6200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.In this case, the ring was downsized two sizes, suggesting that this event was due to mis-sizing at the initial time of implantation.The root cause of this event cannot be conclusively determined; however, it appears that this event was due to procedural related factors.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

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, it was learned that a 30 mm tricuspid annuloplasty ring, implanted two (2) years and six (6) months, was explanted due to tricuspid regurgitation and partial dehiscence of the ring.Per medical records, this case involved a (b)(6)-year-old female with a history of aortic, mitral and tricuspid valve repair.She presented with severe recurrent tricuspid regurgitation and severe aortic insufficiency.Echocardiogram confirmed partial dehiscence of the tricuspid ring with severe tricuspid regurgitation.Intraoperatively, there was evidence of partial tricuspid ring dehiscence.The ring was excised and a smaller 26 mm tricuspid ring was seated and sutured into place with corknot device.Aortic valve was also performed.She was weaned from cpb.She was transferred to icu in satisfactory condition.The patient was discharged to a nursing facility on pod #10 in stable condition.

• Brand Name: CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7275298
• MDR Text Key: 100231423
• Report Number: 2015691-2018-00540
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2019
• Device Model Number: 6200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Date Device Manufactured: 02/25/2014
• 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: 62 YR