MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the subject device is not available for evaluation as it remains implanted in the patient.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 a right coronary artery (rca) obstruction occurred during implant procedure with a 11500a27 valve leading to a bypass graft.As reported, during procedure, a 27mm inspiris valve was implanted and all sutures were secured with a core-knot.During cardiopulmonary bypass weaning, a rise in st segments was noticed on the electrocardiograph (ecg).The surgeon suspected there was a dynamic obstruction from the strut of the valve to the right coronary ostia.For safety reasons, the surgeon elected to harvest a small amount of distal vein from the left leg and perform an off-pump anastomosis between the aortic graft and the proximal right coronary artery.The saphenous vein graft to rca was successful and the ecg normalized.The patient weaned easily from cardiopulmonary bypass and heparin was reversed with protamine before decannulation uneventfully.The patient was transferred to the intensive care unit in a satisfactory hemodynamic state and was eventually discharged home.

Manufacturer Narrative

Added information to section h6 (device code(s)), h6 (investigation findings) and h6 (investigations conclusions) corrected data h6 (device code(s)): "4001 - patient device interaction problem" code removed.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The device was not returned for evaluation.Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement.It is typically the result of a technical error during valve implant and not related to a device malfunction.The most likely cause is procedural factors.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• 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: 17866745
• MDR Text Key: 324866727
• Report Number: 2015691-2023-16512
• 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
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Male