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

Model Number 4450

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Endocarditis (1834); Mitral Regurgitation (1964)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

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.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Although the root cause of this event cannot be conclusively determined, this infection was likely related to contamination at the time of surgery.Edwards will continue to review of all reported events and perform trend analysis on a monthly basis.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, it was reported that a mitral ring, implanted for one (1) month, was explanted due to regurgitation and dehiscence secondary to staph endocarditis.The explanted device was replaced with an edwards bioprosthetic valve.The patient also underwent an aortic valve replacement.There were no intraoperative complications and the patient was taken to the icu in critical but stable condition.The patient was discharged home in stable condition on pod #11.

• Brand Name: CARPENTIER-EDWARDS PHYSIO 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: 7061981
• MDR Text Key: 93032336
• Report Number: 2015691-2017-04004
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2021
• Device Model Number: 4450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Date Device Manufactured: 06/08/2016
• 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: 54 YR