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

Model Number 3300TFX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

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 3300tfx27mm implanted in aortic position was explanted from a 73-year-old patient after an implant duration of three (3) months and nineteen (19) days due to endocarditis leading to stenosis.It was informed that valve leaflets were heavily affected and endocarditis spread throughout the whole heart.Onset date was predicted to be around (1) one month after index surgery.As reported, patient presented with heavy shortness of breath.Another valve of same model but one size smaller (25mm) was implanted in replacement.Unfortunately patient passed away on post-operative day 1.As reported, cause of patient's death was unknown but unrelated to any of the edwards devices.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date).Updated section b4 (date of this report), g3 (date received by manufacturer), h6 ( component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).H10: additional manufacturer narrative: 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.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.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 perioperatively, most of which probably occurs intraoperatively.Besides the patients 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.Since there are multiple modes of contamination other than the prosthesis itself, and no indication or allegation that the patients infection was device related, the event was likely due to patient and/or procedural related factors.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed to the event.

• 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 ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18622709
• MDR Text Key: 334322601
• Report Number: 2015691-2024-00708
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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; Death
• Patient Age: 73 YR
• Patient Sex: Male