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

Model Number 11500A

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/28/2023

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 about a potential coronary artery obstruction after implantation of a 19mm inspiris resilia valve in aortic position.As reported, the valve was implanted in the supra-aortic position and after checking that both coronary ostia were free, the aortotomy was closed.However, a greater st shift was observed which might have been caused by an obstacle on the right coronary artery at the level of the ostium.The intraoperative tee showed that the flow was permeable at the level of the ostium and perhaps one of the bioprosthesis posts was decreasing the flow at that level.At that point, it was decided to solve it with a single saphenous bypass.Echo performed intra-operatively showed proper functioning of the aortic prosthesis and good left and right ventricular function.The patient was discharged to recovery the same day.

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.

Manufacturer Narrative

Added information to section d4 (serial number), h6 (health effect - impact code), h6 (investigation findings) and h6 (investigations conclusions).Corrected data h6 (health effect - impact code): "4625 - additional surgery" removed.H10: additional manufacturer narrative: the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.In addition, the event does not allege a labeling issue or device related infection, therefore no dhr review is required.The device was not returned for evaluation as it remained implanted.Coronary flow obstruction is a known potential adverse event associated with the prosthetic valve procedures.Coronary obstruction can result in myocardial ischemia or infarction due to obstruction of the coronary blood flow and may require intervention (intra-aortic balloon pump or extracorporeal membrane oxygenation) to treat ventricular dysfunction secondary to the coronary obstruction.In addition, to treat the occlusion, a coronary artery bypass graft or percutaneous coronary intervention could be required.Coronary occlusion is typically the result of a technical error during valve implant and not related to a product malfunction.It occurs because the commissure of the biosprosthetic valve occludes the ostia (for aortic valve procedures) or there is an interaction with the coronary arteries in the mitral (circumflex artery) or tricuspid position (right coronary artery), which restricts blood flow.Based on the information available, the most likely cause is patient/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: 17931566
• MDR Text Key: 325622168
• Report Number: 2015691-2023-16784
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• 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: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 66 KG