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

Model Number 11060A

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/20/2023

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation.As it remains implanted in the patient.A video taken during the procedure was provided and reviewed.Customer report of blood leakage through the gelweave was confirmed through image review.One (1) video was provided showing the valve conduit implanted.Heart was bumping and blood leakage was visible homogeneously through the conduit tissue.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

Edwards received notification, that excessive blood leakage was observed through the gelweave of this konect aortic valved conduit model 11060a21 after suturing.As reported, there was no leakage at the suture points or paravalvular, only through the gelweave tissue.During surgery the patient lost 1050 ml of blood.Reportedly, leakage reversed after use of protamine.As reported, the patient received platelets and clotting factors.The patient did not suffer any adverse event or injury, due to the bleeding and was noted as to be in stable condition.As reported, the patient was under preoperative antiplatelet agents (aspirin 100mg/day).As reported, a needle was inserted in the graft to deair the heart, but the bleeding was not though that point.The tube was hydrated in saline solution for approximately 1.5 minutes.Reportedly, the doctor had experience using the konect and had not had any similar experience before.

Manufacturer Narrative

H10: additional manufacturer narrative: customer report of "blood leakage through the gelweave" was confirmed through image review.One (1) video was provided showing the valve conduit implanted.Heart appeared to be pumping and blood appeared to be leaking through the gelweave graft of the device.One picture showed the valve conduit during the implant and another one with the ipr paperwork with device data were also provided.

Event Description

Edwards received notification that excessive blood leakage was observed through the gelweave of this konect aortic valved conduit model 11060a21 after suturing.As reported, there was no leakage at the suture points or paravalvular, only through the gelweave tissue.A video was provided.During surgery the patient lost 1050 ml of blood.Reportedly, leakage reversed after use of protamine.As reported, the patient received platelets and clotting factors.The patient did not suffer any adverse event or injury due to the bleeding and was noted as to be in stable condition.As reported, the patient was under preoperative antiplatelet agents (aspirin 100mg/day).As reported, a needle was inserted in the graft to deair the heart but the bleeding was not though that point.The tube was hydrated in saline solution for approximately 1.5 minutes.Reportedly, the doctor had experience using the konect and had not had any similar experience before.A video was provided and reviewed.Customer report of "blood leakage through the gelweave" was confirmed through image review.One (1) video was provided showing the valve conduit implanted.Heart was bumping and blood leakage was visible homogeneously through the conduit tissue.

Manufacturer Narrative

Corrected section b2 (outcomes attributed to adverse event (check all that apply).H10: 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.The device was not returned for evaluation as it remained implanted, however, pictures and one video were provided for evaluation.Per the image evaluation, the customer's report of blood leakage through the graft was confirmed.Dhr review was performed and no relevant non-conformances were identified and no other similar incidents were identified during the lot history review.The ifu states, the konect resilia avc must be immersed in a sterile saline solution for 5 minutes.Thereafter, the konect resilia avc must be kept hydrated with saline throughout the remainder of the procedure and must not be allowed to dry out, however, the subject device was hydrated for approximately 1.5 minutes.Based on the information available, the most likely cause of the reported blood leakage through the graft is use error of insufficient time spent immersing the device in saline.An edwards defect has not been confirmed.

• 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: 17296261
• MDR Text Key: 318920053
• Report Number: 2015691-2023-14499
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: 11060A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Patient Outcome(s): Life Threatening; Hospitalization; Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male