MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11060A

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

Patient Problems Endocarditis (1834); Insufficient Information (4580)

Event Date 07/18/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

Through implant patient registry it was learned that a 27mm 11060a valved conduit was explanted after an implant duration of 1 (one) month, 11 days due to unknown reasons.The explanted valve was replaced with a 27mm 11060a valved conduit.Patient was in recovery post procedure.

Event Description

Through implant patient registry and investigation, it was learned that a 27mm 11060a valved conduit was explanted after an implant duration of 1 (one) month, 11 days due to endocarditis (mssa).The explanted valve was replaced with a 27mm 11060a valved conduit.Per medical records, patient was found to have stroke in the setting of prosthetic av and native mv endocarditis.The patient underwent redo- avr and aortic root replacement with 27mm konect valved conduit, cabrol grafting of the coronary buttons, ascending aorta replacement and bovine patch repair of aortic root abscess.Post bypass tee showed a well-seated aortic root graft.The patient was transferred to icu in stable condition.

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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.

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.Prosthetic endocarditis occurring within sixty days of valve implantation generally reflects contamination arising in the perioperative period.There are many opportunities for organisms to seed a prosthesis perioperatively, most of which probably occurs intraoperatively.Besides the patients 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.Since there are multiple modes of contamination other than the prosthesis itself, and no indication or allegation that the patients infection was device related, the event was likely due to patient and or procedural related factors.The root cause of this event was prosthetic endocarditis within sixty days of valve implantation.The subject device is not available for evaluation.The device history record review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492500222
• MDR Report Key: 17654849
• MDR Text Key: 322330811
• Report Number: 2015691-2023-15582
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103201390
• UDI-Public: (01)00690103201390(17)250321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11060A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• 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; Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male