MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number 460032MM

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Endocarditis (1834); Thrombosis (2100)

Event Date 05/17/2019

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 root cause of this event cannot be conclusively determined with the available information.However, the early endocarditis was most likely due to patient and/or procedural related factors.The subject device was not returned for evaluation due to infection.Edwards will continue to review and monitor all reported 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.It was reported that a 32mm annuloplasty ring, implanted in the mitral position, was explanted after an implant duration of two (2) months due to endocarditis.The explanted ring was replaced with a 33mm 7300tfx pericardial mitral valve.Per the operative report, the annular ring was intact, the valve was competent but there was severe amount of endocarditis on the annuloplasty ring and draped over the posterior leaflet.The annuloplasty ring was excised and there was a small annulus abscess underneath of it.This was extensively debrided.The entire posterior leaflet and subvalvular apparatus with the anterior leaflet was excised to remove all infected tissue.There was a second abscess on the anterior leaflet at the a3 cusp, which was debrided.The annulus was sized to a 33mm sizer, which fit appropriately.The 33mm 7300tfx mitral valve was selected.Horizontal mattress fashion with pledgets were placed.The valve was seated and sutures were secured with cor-knot device.The valve was inspected and found to be well-seated and free from the lvot.The patient was rewarmed, weaned, and separated from bypass without difficulty.Tee demonstrated a properly functioning pericardial mitral valve.The patient tolerated the procedure well and was taken to the icu in stable condition.

Manufacturer Narrative

The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8753129
• MDR Text Key: 149796893
• Report Number: 2015691-2019-02415
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2019

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: 11/16/2022
• Device Model Number: 460032MM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/10/2019; 07/23/2020
• Supplement Dates FDA Received: 07/30/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR