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); Detachment of Device or Device Component (2907)

Patient Problem Abdominal Pain (1685)

Event Date 04/27/2021

Event Type  Injury  

Event Description

It was reported via the implant patient registry that a 23mm aortic valve, implanted for 25 days, was explanted due to severe regurgitation due to perivalvular leak and dehiscence.The explanted device was replaced with a 23mm valve.Per medical records the patient presented with abdominal pain with associated vomiting.Echo showed severe ar with pvl.There were concerns for a possible abscess in the area of the pvl.However, three sets of blood cultures were negative.The patient underwent redo-avr and ascending aortic replacement with a 28mm hemashield platinum graft.Intraoperatively the valve was dehisced in the area of the left and noncoronary commissures.There was no evidence of any aortic abscess.Exam of the left coronary leaflet appeared to have early vegetation on the aortic side which was cultured, and rapid gram stain showed no evidence of any bacteria.There were no inspiris valves available and a 23mm valve was implanted in replacement.Post-implant tee showed a well-seated valve with no pvl.The patient was transferred to icu in stable, but critical condition.On pod #3, a ppm was placed due to chb.The patient was discharged home in stable condition on pod #9.Edwards lifesciences maintains an implant patient registry.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.

Manufacturer Narrative

Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve 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.The device was not returned for evaluation, as device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

Updated d4, h4, and h6 per new information received.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were 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, appropriate investigation will be performed.

• 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: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14523490
• MDR Text Key: 292822522
• Report Number: 2015691-2022-05945
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)241014(11)201015217128223
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male