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

Model Number 11060A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification that a konect model 11060a23 was explanted the same day of implant due to dehiscence from the annulus of the patient.There was no allegation of device malfunction.Another konect model 11060a size 21 was successfully implanted in replacement.As reported, patient had significant blood loss, heart arrested after decannulation and the team decided not to resuscitate further and patient died.There was no allegation that the device was implicated.The surgeon was very experienced with konect.

Manufacturer Narrative

H11: additional manufacturer narrative: 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.Device dehiscence or suture torn out may occur early or late.When it occurs in the intraoperative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Valve dehiscence is not a malfunction related to a manufacturing deficiency of the device.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

Event Description

Edwards received notification that a konect model 11060a23 was explanted after an unknown duration due to dehiscence from the annulus of the patient.There was no allegation of device malfunction.Another konect model 11060a size 21 was successfully implanted in replacement.As reported, patient had significant blood loss, heart arrested after decannulation and the team decided not to resuscitate further and patient died.There was no allegation that the device was implicated.The surgeon was very experienced with konect.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18996840
• MDR Text Key: 338881842
• Report Number: 2015691-2024-02379
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)241004
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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