MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number 3300TFX

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Endocarditis (1834)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Through implant patient registry and investigation, it was learned that a 21mm 3300tfx valve was explanted after an implant duration of 7 years, 2 months due to paravalvular leak (pvl).Per pathology, patient had endocarditis at time of explant.Patient presented with shortness of breath.The explanted valve was replaced with a 21mm 11500a valve.Patient was stable at the end of the procedure.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

Prosthetic endocarditis with or without vegetation, of valves and annuloplasty rings is a serious complication of 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).Late prosthetic endocarditis resembles native valve endocarditis in terms of etiological microbes, and sources of contamination are presumably similar.Late endocarditis occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body.Dental, genitourinary, and gastrointestinal manipulation are known causes of transient bacteremia, which can place a patient at risk for prosthetic endocarditis.Additional procedures placing patients at risk for prosthetic endocarditis include urethral catheterization, colonoscopy, barium enemas, and surgical procedures.In this case patient had late endocarditis.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Through implant patient registry and investigation, it was learned that a 21mm 3300tfx valve was explanted after an implant duration of 7 years, 2 months due to paravalvular leak (pvl) secondary to mrsa bacteremia/endocarditis.Tee demonstrated vegetations with severe aortic insufficiency and peri annular abscess.Patient presented with shortness of breath, heart failure, fever, generalized malaise, confusion, and septic shock.The explanted valve was replaced with a 21mm 11500a valve.Patient was stable at the end of the procedure.Patient has recovered and was discharged from the hospital.Hospital pathology report: fibrinopurulent exudate with bacterial colonies, endocarditis.Prosthetic valve has cusps with friable tan material.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16401448
• MDR Text Key: 309884515
• Report Number: 2015691-2023-10953
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176131
• UDI-Public: (01)00690103176131(17)190826
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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: 3300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/27/2023
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male