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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

Patient Problems Aortic Valve Stenosis (1717); Failure of Implant (1924); Liver Damage/Dysfunction (1954); Mitral Regurgitation (1964)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The device was not returned to edwards for evaluation as it remains implanted.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 heart is a multivalvular system with heart valves function to promote coordinated forward blood flow during the cardiac cycle.Repairing or replacing one valve might affect the function of another valve by changing the heart structure and/or the hemodynamics.Additional unplanned intervention might be required to restore the normal forward blood flow.In this case, the patient had moderate systolic anterior motion and mitral regurgitation before the implant of an aortic valve; however, the systolic anterior motion and mitral regurgitation became severe after the avr.The patient underwent a redo avr with an edwards aortic valve and a concomitant mvr with a non-edwards valve on pod#3.A manufacturing related issue was not identified.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a 25mm aortic valve implanted for three days was explanted to replace the mitral valve due to severe systolic anterior motion (sam) and mitral regurgitation (mr).The patient did have moderate sam/mr before the implant of the 25mm aortic valve.The sammr became severe after the aortic valve replacement.Another 25mm valve was implanted in replacement.The patient also received a 29mm non-edwards mitral valve during the procedure.Per received records, this case involved a (b)(6) year old female with multi-vessel cad and moderate aortic stenosis.Under transesophageal echocardiography intraoperatively, the aorta was assessed to reveal normal aorta and moderate aortic stenosis.At lower blood pressures, the patient did develop mitral regurgitation with moderate sam due asymmetric septal hypertrophy.The patient underwent a coronary artery bypass graft x2, septal myomectomy, and aortic valve replacement with a 25mm 11500a valve.The patient continued to have sam physiology after the initial operation.After three days, transesophageal echocardiogram was performed which showed severe systolic anterior motion of the mitral valve leaflet with severe mitral regurgitation.It was decided that the sam physiology was too extreme.The patient had developed suicide ventricle physiology due to the severe hypertrophic cardiomyopathy.The patient was emergently taken to the operating room to undergo mitral valve replacement.The previously placed 25mm aortic valve was removed to improve visualization of the mitral valve.The patient received a 29mm non-edwards mitral valve and a 25mm aortic valve.The patient returned to sinus rhythm and was weaned and separated from cardiopulmonary bypass.Echocardiographic examination revealed a well seated prosthesis with no evidence of paravalvular leak and appropriate leaflet function.

Event Description

It was reported that a patient with a 25mm valve implanted for three days underwent redo aortic valve replacement and mitral valve replacement due to severe systolic anterior motion (sam) and mitral regurgitation (mr).The patient had moderate sam/mr before the implant of the 25mm 11500a aortic valve; however, the sam/mr became severe after the aortic valve replacement.The patient received a 29mm non-edwards mitral valve and a 25mm aortic valve.The patient returned to sinus rhythm and was weaned and separated from cardiopulmonary bypass.Echocardiographic examination revealed a well seated prosthesis with no evidence of paravalvular leak and appropriate leaflet function.The patient was discharged on pod #21.Per received records, under transesophageal echocardiography intraoperatively, the aorta was assessed to reveal normal aorta and moderate aortic stenosis.At lower blood pressures, the patient did develop moderate mitral regurgitation with sam physiology due asymmetric septal hypertrophy.The patient underwent a coronary artery bypass graft x2, septal myomectomy, and aortic valve replacement with a 25mm valve.The patient continued to have sam physiology after the initial operation.After three days, transesophageal echocardiogram was performed which showed severe systolic anterior motion of the mitral valve leaflet with severe mitral regurgitation.It was decided that the sam physiology was too extreme.The patient had developed suicide ventricle physiology due to the severe hypertrophic cardiomyopathy.The patient was emergently taken to the operating room to undergo mitral valve replacement.The previously placed 25mm aortic valve was removed to improve visualization of the mitral valve.The patient received a 29mm non-edwards mitral valve and a 25mm 3300tfx aortic valve.The patient returned to sinus rhythm and was weaned and separated from cardiopulmonary bypass.Echocardiographic examination revealed a well seated prosthesis with no evidence of paravalvular leak and appropriate leaflet function.The patient was extubated and continued to progress slowly but improving daily.The patient did require a permanent pacemaker.The patient was discharged on pod #21.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections b5 and b7.

Manufacturer Narrative

H11.Corrected data - updated section h6 (result).

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10276102
• MDR Text Key: 198947186
• Report Number: 2015691-2020-12522
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR