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

Model Number 11500A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Endocarditis (1834); Fever (1858); Malaise (2359)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be retrieved.There is no indication or allegation of product malfunction.Attempts to retrieve additional information is in process.If additional information is received a supplemental mdr will be submitted.Prosthetic endocarditis, with or without vegetation, of valves and annuloplasty rings is a serious complication of cardiac valve replacement and valve repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset occurs at 60 days or less post-implant) and late (onset greater than 60 days post-implant).Prosthetic endocarditis occurring within 60 days of valve or ring implantation generally reflects contamination arising in the perioperative period.There are many opportunities for organisms to seed a prosthesis peri-operatively, most of which probably occurs intraoperatively.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.If there were ever non-conformances in the sterility or packaging processes, they would most likely manifest in the early post-operative period.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.A lot history view was performed and no events with the same defect were found.The cause of the event cannot be determined; however, patient and procedural factors may have contributed to the 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.

Event Description

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.Edwards implant patient registry received information a 19mm aortic valve was explanted after implant duration of 20 days due to (b)(6) bacterial endocarditis.Patient represented to hospital with purulent sternal wound drainage, fever, and malaise.The patient had positive blood cultures for (b)(6) bacteremia.Patient treated with antibiotics.There was no vegetation on the leaflets with moderate amount of biofilm on sewing ring consistent with infection.Patient had massive pus surrounding graft consistent with mediastinal abscess.The explanted device was replaced with a 21mm aortic valve.The patient also underwent ascending aortic hemiarch replacement with 21mm homograft tube during procedure.Valve function was normal and no leaks were seen.Required defib x 2 coming off bypass for vfib, and was briefly paced, now in nsr x 4h prior to arrival to cticu.The patient was transported intubated, in stable condition to the cticu.Records indicated patient had cardiogenic postoperative shock.Patient was discharged home on post-operative day seven (7).

Manufacturer Narrative

H11.Corrected data: corrected g4 date on initial mdr.Correct date is july 6, 2020.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated h6 result code.H11.Corrected data: remove h6 conclusion code- cause cannot be trace to device.

Manufacturer Narrative

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

• 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
• MDR Report Key: 10343280
• MDR Text Key: 202353915
• Report Number: 2015691-2020-12801
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• 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: 70 YR
• Patient Weight: 83