MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number 7300TFX

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Udi # (b)(4).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 occurs at 60 days or less post-implant) and late (onset greater than 60 days post-implant).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.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.It is unknown whether patient and/or procedural related factors may have caused or contributed to the event.The subject device was not returned for evaluation due to infection and as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

It was reported that a patient with a 27mm 7300tfx mitral valve exhibited endocarditis after an implant duration of approximately 14 days.Of note, a 21mm 11500a aortic valve exhibited endocarditis no less than 14 days post implant.The hospital's internal infection control department is currently conducting their investigation, including bacterial phenotyping.It was noted that there were other valves from different manufacturer involved as well.No other details were provided.

Manufacturer Narrative

H11: corrected data: corrected sections b5, h10 (additional manufacturer narrative).Av disruption (disassociation) is a dreaded and often fatal complication.This is an extreme form of posterior lv rupture where a portion or the entire posterior left atrium separates from the left ventricle.The risk of this occurrence is greatest in patients with extensive calcification in the posterior mitral annulus and leaflet.This finding is common in elderly patients undergoing mitral valve surgery and is evident by preoperative imaging, including echocardiography and cardiac catheterization.Chest computed tomography without intravenous contrast can be useful in quantifying the degree of posterior mitral annular calcification (also known as mac).Av disruption (disassociation) is usually related to vigorous traction or debridement of the posterior leaflet of the valve or to calcium excision in a calcified posterior leaflet.This can cause separation of the av groove, leading to massive hemorrhage upon separation from cardiopulmonary bypass.This complication is prevented by understanding the pathologic process of calcification of the mitral annulus and avoiding rupture by either placement of traction sutures on the edge of the posterior leaflet or by very careful calcium debridement only in isolated spots.A safer procedure may be to attach the prosthesis to the atrial wall, leaving the entire calcified mass intact.This approach may result in a smaller valve area but a successful operation.When this complication occurs, valve prosthesis is removed, and the ventricle is reapproximated to the left atrium with felt strips.Often, a pericardial patch is used to cover the defect and the valve sutures are now placed into the pericardial patch.Nevertheless, this complication carries a high mortality.The root cause of this event cannot be conclusively determined with the available information.However, it was likely due to procedural related factors that may have caused or contributed to the event.The subject device was not returned for evaluation as it was likely discarded per the customer.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.Please reference mfr report #2015691-2020-14247 & 2015691-2020-14800 that were submitted for other adverse events related to this patient.

Event Description

Per the valve coordinator, the hospital's internal infection control department is currently conducting an investigation on the cause for cluster infections, and requested an investigation on the implanted valves as a potential root cause (early endocarditis).They are currently conducting bacterial phenotyping.It was noted that there were other valves from different manufacturer involved in this cluster.No other details were provided.Per medical records, the 27mm 7300tfx mitral valve was explanted after an implant duration due to prophylactic reason on pod #1 to repair an av dissociation.There was hemorrhagic shock and bleeding.A 25mm 7300tfx mitral valve was implanted in replacement.The patient's newly replaced 25mm 7300tfx mitral valve and 21mm 11500a aortic valve were subjected to sepsis likely brought on by serratia and klebsiella pneumonia.The patient experienced cardiogenic and septic shock, multi-organ failure, a-fib/flutter, and chb.On pod #7, the patient expired due to complications from a ventricular perforation, which occurred during the initial mvr, avr, tv repair and laa procedure, prior to the mvr redo.There was no investigational evidence of endocarditis on all valves; however, the possibility of early endocarditis exists for 25 mm 7300tfx mitral valve and the 11500a aortic valve, due to septic conditions.

Manufacturer Narrative

H11: corrected data: corrected section h6 (results & conclusions codes).

Manufacturer Narrative

H10: additional manufacturer narrative: updated section b5, f10 (device code).Corrected sections h6 (method codes), h10 (additional manufacturer narrative) av disruption (disassociation) is a dreaded and often fatal complication.This is an extreme form of posterior lv rupture where a portion or the entire posterior left atrium separates from the left ventricle.The risk of this occurrence is greatest in patients with extensive calcification in the posterior mitral annulus and leaflet.This finding is common in elderly patients undergoing mitral valve surgery and is evident by preoperative imaging, including echocardiography and cardiac catheterization.Chest computed tomography without intravenous contrast can be useful in quantifying the degree of posterior mitral annular calcification (also known as mac).Av disruption (disassociation) is usually related to vigorous traction or debridement of the posterior leaflet of the valve or to calcium excision in a calcified posterior leaflet.This can cause separation of the av groove, leading to massive hemorrhage upon separation from cardiopulmonary bypass.This complication is prevented by understanding the pathologic process of calcification of the mitral annulus and avoiding rupture by either placement of traction sutures on the edge of the posterior leaflet or by very careful calcium debridement only in isolated spots.A safer procedure may be to attach the prosthesis to the atrial wall, leaving the entire calcified mass intact.This approach may result in a smaller valve area but a successful operation.When this complication occurs, valve prosthesis is removed, and the ventricle is reapproximated to the left atrium with felt strips.Often, a pericardial patch is used to cover the defect and the valve sutures are now placed into the pericardial patch.Nevertheless, this complication carries a high mortality.The root cause of this event cannot be conclusively determined with the available information.However, it was likely due to patient related factors that may have caused or contributed to the event.The subject device was not returned for evaluation as it was likely discarded per the customer.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.Please reference mfr report#: 2015691-2020-14247 for the report submitted on the patient's replacement mitral valve.

Event Description

It was reported that a patient with a 27mm 7300tfx mitral valve was explanted after an implant duration due to prophylactic reason on pod #1 to repair an av dissociation.There was hemorrhagic shock and bleeding as well.A 25mm 7300tfx mitral valve was implanted in replacement.Of note, the patient's newly replaced 25mm 7300tfx mitral valve and 21mm 11500a aortic valve were subjected to sepsis likely brought on by serratia and klebsiella pneumonia.The patient experienced cardiogenic and septic shock, multi-organ failure, a-fib / flutter, and chb.The patient expired due to ventricular perforation, which occurred post redo mvr, avr, tv repair, laa, and cabg x3.The hospital's internal infection control department is currently conducting their investigation, including bacterial phenotyping.It was noted that there were other valves from different manufacturer involved as well.No other details were provided.There was no investigational evidence of endocarditis on all valves; however, the possibility of early endocarditis exists for the implanted 25mm mitral valve and 21mm aortic valve.

Manufacturer Narrative

H10: additional manufacturer narrative: additional information received from the customer indicating that their investigation confirmed that the edward valves were not identified as the fomite.Edwards investigation also concluded that there was no investigational evidence of early endocarditis in all cases reported by this site.  h11: corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10786509
• MDR Text Key: 214599872
• Report Number: 2015691-2020-14246
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR