MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART-VALVE

Model Number UNKNOWN MITRAL VALVE

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional 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.

Event Description

It was reported that a patient with a 27mm magna mitral valve underwent a valve-in-valve procedure after an unknown implant duration due to mitral stenosis, regurgitation, and endocarditis.The patient presented with chf.The tmvr was performed with a 26mm 9755rsl transcatheter valve.The patient was in recovery post procedure.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, g3, g6, h2, h3, h6 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 prosthesis types, surgical techniques, and infection control measures.It can be categorized as early (within 2 months), intermediate (between 2 and 12 months), or late (>12 months).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, 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.Intermediate, or late endocarditis (greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patients body and is not in any way related to the sterilization or packaging process of the device.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.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: NI
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irivne CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17232161
• MDR Text Key: 318176028
• Report Number: 2015691-2023-14264
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MITRAL VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2023
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male