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

Model Number 11500A21

Device Problem Perivalvular Leak (1457)

Patient Problems Corneal Pannus (1447); Endocarditis (1834); Unspecified Infection (1930)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Udi #: (b)(4).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 usually less than 60 days postoperative) and late (onset greater than 60 days post-implantation).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.Besides the patient's own skin and access lines, several other important modes of contamination have been recognized including air in the operating room, the coronary suction devices used during surgery and the heart-lung bypass machine, faulty technique during cardiac output measurements, and the prosthesis itself.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.Perivalvular leak (pvl) can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Host fibrous (pannus) tissue growth is expected in all prosthetic/bioprosthetic heart valves and largely attributable to the host response (such as the foreign body reaction) to the implants.In vast majority cases, the pannus tissue is from surrounding native anatomy such as annulus.The time course and severity of pannus growth is largely variable among the patients.The underlying mechanism is still not fully understood, but it is generally believed that the patient factors (such as patient immune system, age, other comorbidities, local anatomy et.Al.) may play important roles in pannus growth in bioprosthetic heart valves.In this case, the root cause was due to patient related factors.It was noted that the patient had an infection with propionibacterium acne.There was no allegation or evidence of a device malfunction.The subject device was not returned for evaluation due to infection.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.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 received notification that this 21mm aortic pericardial valve was explanted after an implant duration of 47 days due to paravalvular leak (pvl) caused by endocarditis.The patient had an infection with propionibacterium acnes.There was no endocarditis prior to the implant.Four (4) weeks post implant, pvl and pannus formation was detected on echo.Within the next six (6) days, the pvl became larger; therefore, the valve was explanted.A patch was used to re-build the aortic root and a non-edwards valve was implanted as replacement.The surgeon was concerned about the microorganism found and it is rare and grows slowly.Two leaflets from the inspiris valve were sent to the hospital laboratory for analysis.

Event Description

Edwards received notification that this 21mm aortic pericardial valve was explanted after an implant duration of 47 days due to paravalvular leak (pvl) caused by endocarditis with vegetation.The patient had an infection with propionibacterium acnes.There was no endocarditis prior to the implant that was done under minimally invasive surgery.The postoperative course was initially well and the patient was discharged to rehabilitation at another hospital on pod #9.There, the patient had recurrent chills and hot flashes with sub-febrile temperature about 2 weeks.The patient complained about double vision, motor aphasia and recurrent vertigo.Ischemia in the right parietal occipital was finally detected on ct scan.Positive blood cultures for gram-positive rods and propionibacterium acnes were finally obtained after 42 days of the implant.Four (4) weeks post implant, a large vegetation and pvl was detected on echo for the first time.The patient received antibiotic treatment with penicillin and was referred to surgery.Within the next six (6) days, the pvl became larger; therefore, the valve was explanted.At explant, valvular and subvalvular vegetations were found.After removal of all the infected tissue, a patch was used to re-build the aortic root and a non-edwards valve was implanted as replacement.The patient was in stable hemodynamic conditions and was reported to be doing well postoperatively.Taking into account that the patient had no symptoms within the first 2 weeks, the surgeon was concerned about the microorganism found because it is rare and grows slowly.During investigation of this event, there was another new case of early endocarditis after the implant of an inspiris valve reported by the same surgeon.The surgeon has been implanting edwards valves only since the release of inspiris (never implanted other edwards valves) and his concerned about this endocarditis infections is because the two surgeries were performed by different medical teams.No other case of endocarditis has been reported by the team on any other implanted prosthesis these last months, and p.Acne has not been found elsewhere (instruments and cpb circuits).They are performing dna tests on these two samples to find out if they are of the same strain, which would reinforce the likelihood for external contamination (not from patient) irrespectively of its source.

Manufacturer Narrative

Evaluation summary: report of endocarditis was confirmed through image evaluation.Pictures provided appeared to show large amounts of vegetation on the inflow surfaces of all three leaflets.Device was returned for evaluation.Customer report of endocarditis was confirmed through observed vegetation during pre-decontamination and through image evaluation.X-ray demonstrated wireform intact.As received, leaflet 1 had a cut out of approximately 9mm x 8mm on leaflet 1.Moderate host tissue overgrowth was observed on the stent circumference on the inflow and outflow aspects.Multiple suture pledgets remained attached to the sewing ring on the inflow aspect of the valve.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 usually less than 60 days postoperative) and late (onset greater than 60 days post-implantation).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.Besides the patient's own skin and access lines, several other important modes of contamination have been recognized including air in the operating room, the coronary suction devices used during surgery and the heart-lung bypass machine, faulty technique during cardiac output measurements, and the prosthesis itself.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.In this case, the root cause cannot be conclusively determined.There was no evidence of a product non-conformance.Endocarditis is a potential adverse event associated with the use of valves and the surgical procedure.Per the instructions for use (ifu), "adverse events due to individual patient reaction to an implanted device or to physical or chemical changes to the components, particularly those of biological origin, may occur at varying intervals (hours or days) necessitating reoperation and replacement of the prosthetic device." 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.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 received notification that this 21mm aortic pericardial valve was explanted after an implant duration of 47 days due to paravalvular leak (pvl) caused by endocarditis with vegetation.The patient had an infection with propionibacterium acnes.There was no endocarditis prior to the implant that was done under minimally invasive surgery.The postoperative course was initially well and the patient was discharged to rehabilitation at another hospital on pod #9.There, the patient had recurrent chills and hot flashes with sub-febrile temperature about 2 weeks.The patient complained about double vision, motor aphasia and recurrent vertigo.Ischemia in the right parietal occipital was finally detected on ct scan.Positive blood cultures for gram-positive rods and propionibacterium acnes were finally obtained after 42 days of the implant.Four (4) days later, a large vegetation and pvl was detected on echo for the first time.The patient received antibiotic treatment with penicillin and was referred to surgery.At explant, valvular and subvalvular vegetations were found.After removal of all the infected tissue, a patch was used to re-build the aortic root and a non-edwards valve was implanted as replacement.The patient was in stable hemodynamic conditions and was reported to be doing well postoperatively.Taking into account that the patient had no symptoms within the first 2 weeks, the surgeon was concerned about the microorganism found because it is rare and grows slowly.During investigation of this event, there was another new case of early endocarditis after the implant of an inspiris valve reported by the same surgeon.The surgeon has been implanting edwards valves only since the release of inspiris (never implanted other edwards valves) and his concerned about this endocarditis infections is because the two surgeries were performed by different medical teams.No other case of endocarditis has been reported by the team on any other implanted prosthesis these last months, and p.Acne has not been found elsewhere (instruments and cpb circuits).They are performing dna tests on these two samples to find out if they are of the same strain, which would reinforce the likelihood for external contamination (not from patient) irrespectively of its source.

Manufacturer Narrative

Reference capa: 20-00141.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8798288
• MDR Text Key: 151312544
• Report Number: 2015691-2019-02616
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention