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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problem Dyspnea (1816)

Event Date 03/09/2023

Event Type  Injury  

Event Description

Edwards received notification that this 59-year-old male underwent reoperation to explant this valve model 11500a25 implanted in aortic position due to perivalvular leakage secondary to dehiscence after thirty-seven (37) days of implantation.Patient was admitted to hospital on post-operative day 23 of initial implantation due to shortness of breath.Outpatient ultrasound cardiogram (ucg) showed normal aortic valve flow rate, a small amount of perivalvular leakage, large left ventricle, thickened left wall, widened ascending aorta and aortic sinus.Six days after admission (post-operative day 29), patient was reported to be in critical condition.Patient underwent reoperation on post-operative day 37.Intraoperative exploration revealed from the incision at the base of the aorta the left coronary cusp of the aortic valve with inflammatory changes in the annulus, tearing at the annular suture site, avulsion of the suture of the valve ring and paravalvular leak.Reportedly, the surgeon removed the subject device and re-implanted it after cleaning.The patient was noted as to be recovering after the procedure.Per medical opinion, the event had nothing to do with the device and, based on the existing medical records, endocarditis was discarded.

Event Description

Edwards received notification that this 59-year-old male underwent reoperation to explant this valve model 11500a25 implanted in aortic position due to perivalvular leakage secondary to dehiscence after thirty-seven (37) days of implantation.Patient was admitted to hospital on post-operative day 23 of initial implantation due to shortness of breath.Outpatient ultrasound cardiogram (ucg) showed normal aortic valve flow rate, a small amount of perivalvular leakage, large left ventricle, thickened left wall, widened ascending aorta and aortic sinus.Six days after admission (post-operative day 29), patient was reported to be in critical condition.Patient underwent reoperation on post-operative day 37.Intraoperative exploration revealed from the incision at the base of the aorta the left coronary cusp of the aortic valve with inflammatory changes in the annulus, tearing at the annular suture site, avulsion of the suture of the valve ring and paravalvular leak.Reportedly, the surgeon removed the subject device and re-implanted it after cleaning.The patient was noted as to be recovering after the procedure.Per medical opinion, the event had nothing to do with the device and, based on the existing medical records, endocarditis was discarded.

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.

Manufacturer Narrative

Added information to section b5 (describe event or problem), b7 (other relevant history, including preexisting medical conditions (e.G allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)), d4 (expiration date) and h4 (device manufacturer date), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) corrected data d6 (d6b.If explanted, give date): device was not explanted clarification d7 (d7a.Is this a single-use device that was reprocessed and reused on a patient?): this field it is marked as no as the device was explanted, washed in the op.Room and implanted again.The device was not reprocessed.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.Device dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Valve dehiscence is not a malfunction of the device.The most likely cause is patient factors, including the inflammatory changes in the annulus causing an avulsion of the suture of the patient's aortic annulus.

Event Description

Edwards received notification that this 60-year-old male underwent reoperation to explant this valve model 11500a25 implanted in aortic position to perivalvular leakage secondary to dehiscence after thirty-seven (37) days of implantation.Patient was admitted to hospital on pod # 23 of initial implantation due to shortness of breath.Outpatient ultrasound cardiography (ucg) showed normal aortic valve flow rate, a small amount of perivalvular leakage, large left ventricle, thickened left wall, widened ascending aorta and aortic sinus.Six days after admission (pod # 29), patient was reported to be in critical condition requiring treatment of oxygen and diuresis.On pod # 30, the patient developed intermittent shortness of breath, which improved two days later.On pod # 37 patient underwent reoperation.Intraoperative exploration revealed inflammatory changes in the annulus at the side of the left coronary cusp, tearing at the annular suture site resulting in avulsion of the suture of the patient's aortic annulus causing paravalvular leak.Reportedly, the original sutures and gaskets were withdrawn, physician removed the previously implanted inspiris valve, cleaned it and then re-implanted it.The valve was checked for good opening and closing, and the aortic root incision was closed by double-layer suture with a 3/0prolene gasket.Per medical opinion, the event had nothing to do with the device.The patient was discharged on pod # 3 and underwent re-hospitalization on pod # 6 with diagnosis of heart failure.Unfortunately, patient experienced cardiac arrest on pod # 8 and passed away.

• 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 ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16752867
• MDR Text Key: 313446529
• Report Number: 2015691-2023-12360
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 59 KG