MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

Model Number 4900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Endocarditis (1834); Tricuspid Regurgitation (2112)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional manufacturer narrative: 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.Prosthetic endocarditis, with or without vegetation, of valves and annuloplasty rings is a serious complication of cardiac valve replacement and valve repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset usually less than 60 days postoperative) and late (onset greater than 60 days post-implantation).Prosthetic endocarditis occurring within 60 days of valve or ring implantation generally reflects contamination arising in the perioperative period.There are many opportunities for organisms to seed a prosthesis peri-operatively, most of which probably occurs intraoperatively.Besides the patient's own skin and access lines, several other important modes of contamination have been recognized including air in the operating room, the coronary suction devices used during surgery and the heart-lung bypass machine, faulty technique during cardiac output measurements, and the prosthesis itself.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.If there were ever non-conformances in the sterility or packaging processes, they would most likely manifest in the early post-operative period.In this case, there was no allegation of device malfunction; however, cause remains indeterminable.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

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, edwards received information that a 28mm tricuspid ring, implanted three (3) months, eighteen (18) days, was explanted due to regurgitation secondary to endocarditis.The explanted device was replaced with a 30mm tricuspid annuloplasty ring.The patient also underwent mitral valve replacement with a non-edwards mechanical valve.The patient was transported to the intensive care unit in critical condition.It was learned that on post operative day six (6) of the 28mm ring being implanted the patient was marked by gram negative sepsis.

• Brand Name: EDWARDS MC3 TRICUSPID ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms t&d 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5796069
• MDR Text Key: 49591898
• Report Number: 2015691-2016-02231
• 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: literature,other,user facilit
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2016

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: 04/06/2020
• Device Model Number: 4900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/14/2016
• Date Device Manufactured: 04/16/2015
• 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: 44 YR