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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The device was explanted > 0 days for unknown reasons.Although there are multiple root causes, valves are typically explanted because they are not functioning optimally.In this case, intervention has been performed.Additional information and product return for evaluation have been requested.However, there has been no response at this time.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 lifesciences maintains an implant patient registry (ipr).This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.It was reported via the implant patient registry that this inspiris resilia valve model 11500a25 was explanted from the aortic position after an implant duration of six (6) months for unknown reason.A valve model 11500a23 was implanted in replacement.This case involved a patient who was 56 years old at the time of the reported event and who was noted as to be in recovery after the procedure.

Manufacturer Narrative

H10: additional narrative: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Edwards lifesciences maintains an implant patient registry (ipr).This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.It was reported via the implant patient registry that this inspiris resilia valve model 11500a25 was explanted from the aortic position after an implant duration of four (4) months due to endocarditis leading to regurgitation.The prosthetic valve was found to have multiple small vegetations.Two months after implant, patient was feeling unwell with fevers and night sweats and was found to have positive blood culture.The infecting organism of endocarditis was enterococcus faecalis after an urinary tract infection (uti).Patient was admitted to hospital and also found to have occipital stroke with his enterococcus faecalis bacteremia.Patient finished six weeks of antibiotics and was readmitted two months later with positive cultures.A valve model 11500a23 was implanted in replacement with no complications.The patient was noted as to be in recovery and feeling well after the procedure and was discharged on pod #30.

• 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; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15103568
• MDR Text Key: 296584069
• Report Number: 2015691-2022-07011
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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: 06/27/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/19/2022
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male