MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number 4900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tricuspid Insufficiency (2111)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.There has been no indication or allegation of a product malfunction or deficiency.The root cause of this event cannot be conclusively determined; however, this event was likely impacted by patient 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 tricuspid annuloplasty ring, implanted eight (8) months, was explanted due to tricuspid insufficiency secondary to fibrosis.The explanted device was replaced with another edwards ring.Per medical records, this case involved a (b)(6) year-old female with a history of htn, hld, ckd, morbid obesity, mvr, tvr, dm type 2 and valvular heart disease.She presented with dyspnea on exertion, fatigue and exercise intolerance.A recent echocardiogram revealed a paravalvular leak and severe mitral regurgitation and tricuspid regurgitation.She underwent a mitral valve replacement and a tricuspid valve repair.Intraoperatively, the tricuspid valve revealed moderate insufficiency with central jets.It was noted that there was some fibrosis between the anterior and septal leaflet.The ring was replaced with a new tricuspid ring.The ring seated nicely and good coaptation of the anterior, posterior and septal leaflets was achieved.It was noted that there was no leak of the valve.She was weaned from cpb without difficulty.The mitral valve was functioning normally with good seating and no abnormalities.The tricuspid valve showed a mild amount of insufficiency.She tolerated the procedure well.She was transferred to cvr unit in stable condition.

• Brand Name: EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
• 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: 7272061
• MDR Text Key: 100118783
• Report Number: 2015691-2018-00522
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020864
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: 4900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/14/2018
• Date Device Manufactured: 02/01/2017
• 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: 73 YR