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

Model Number	11060A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Event or Problem Description
Edwards received notification that a konect model 11060a23 was explanted at implant due to dehiscence from the annulus of the patient.It was successfully replaced before decannulation with another konect model 11060a, size 21.A concomitant coronary artery bypass was performed.As reported, the patient had significant blood loss, and heart arrested after decannulation.The team decided not to resuscitate further, and the patient died.There was no allegation that the device was implicated or malfunctioned.The surgeon was very experienced with konect.
Additional Manufacturer Narrative
Additional information was received through investigation from implant patient registry (ipr).

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: 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
• Report Number: 2015691-2024-02379
• Device Sequence Number: 8265148
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)241004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2024
• Device Model Number: 11060A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/30/2024; 09/14/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/03/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male