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

Model Number 11500A

Device Problem Perivalvular Leak (1457)

Patient Problem Low Cardiac Output (2501)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

Valve explant at implant is typically a result of inappropriate sizing, difficulty seating, distortion of the valve, valve displacement before/after frame expansion, and/or the patient's anatomy, and not a malfunction of the device.There may be cases in which regurgitation is detected by tee prior to the completion of the surgical case and exchange of the valve is required.The root cause of this event cannot be conclusively determined with the available information.The subject device is not available for evaluation as it was never received.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.

Event Description

Through implant patient registry, it was learned that a 23mm 11500a aortic valve was explanted at implant due to pvl secondary to oversizing of the valve.The explanted valve was replaced with a 21mm 2700 aortic valve.Per the medical records, the patient presented with severe insufficiency and stenosis of a previously implanted non-edwards prosthetic aortic valve, severe rheumatic mitral insufficiency, and right-sided heart failure with cor pulmonale and severe pulmonary htn.The patient underwent a redo avr and mvr.There was a large amount of pannus on the left ventricular sides of the non-edwards prosthetic aortic valve.The valve was excised, and all heavily calcified pannus was thoroughly debrided.A 23mm 11500a valve was initially implanted.The valve was a very tight fit, but it was felt that it was probably going to be reasonable; however, upon removal of the aortic cross-clamp, there was a significant perivalvular leak, significant left ventricular distention, and poor aortic root pressure.The cross-clamp was reapplied the aortotomy was reopened.There was a gap underneath the left annulus just below the left main coronary ostium which seemed to be due to an oversized prosthesis choice.The surgeon attempted to place some repair sutures, but he was not pleased with it.The valve was removed and replaced with a 21mm 2700tfx valve.The new valve was seated nicely and firmly along the aortic annulus.There were no gaps anywhere along the suture line.The left main and right main coronary ostia were widely patent and free of obstruction from the prosthesis.A concomitant mvr was performed with a 29mm non-edwards valve.Upon weaning from cpb, the patient's right ventricular function was sluggish and there were frequent arrhythmias.An intraaortic balloon pump was placed.The surgeon was concerned that there was potential right coronary ischemia; therefore, the patient was placed back on bypass and cabg x1 was performed.Tee showed a normally functioning aortic valve prosthetic and mitral valve prosthetic with no leak at either valve.The patient was returned to the icu in critical condition.The postoperative course was complicated by respiratory failure and rv insufficiency.Mediastinal reexploration was performed with no evidence of clot or tamponade.The patient was placed on vv ecmo with rvad configuration on pod #2.The patient was discharged on pod #4.

Manufacturer Narrative

H11: corrective data: corrected section: h6 (investigation findings and investigation conclusions).

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11962263
• MDR Text Key: 255098726
• Report Number: 2015691-2021-03367
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 102