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); Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  Injury  

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 valve model 11500a27 implanted in the aortic position was explanted after an implant duration of four (4) days due to dehiscence leading to paravalvular leakage.As per the surgeon, prosthesis was not properly attached to the aortic annulus.The event was observed on echo on post-operative day 2.As per the echo report provided, there was moderate aortic insufficiency and the main jet was eccentric anterior and suspected of periprosthetic leakage.Average transprosthetic gradient was 7 mmhg.Another edwards valve of the same model and size was implanted in replacement.As reported, patient was discharged home without any complications.

Manufacturer Narrative

H10: additional manufacturer narrative: the device was not returned for evaluation, as customer confirmed it was not available.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 valve model 11500a27 implanted in the aortic position was explanted after an implant duration of four (4) days due to paravalvular leakage secondary to malposition of the device.As per surgeon's opinion, the valve was not well seated on the annulus at the time of implant.The event was observed on echo on post-operative day 2.As per the echo report provided, there was moderate anterior periprosthetic leakage and mild intraprosthetic aortic insufficiency.Average transprosthetic gradient was 7 mmhg.Another edwards valve of the same model and size was implanted in replacement.As reported, patient was discharged home without any complications.

Manufacturer Narrative

H10 manufacturer narrative: 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.The reported paravalvular leak was likely caused by the malposition of the device.Based on the information available, the most likely cause is patient factors, including the thickening of the annulus mentioned in the eco report provided.An edwards defect has not been confirmed.

• 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: 16918767
• MDR Text Key: 315082805
• Report Number: 2015691-2023-12943
• 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,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male