MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC MITRIS RESLIA MITRAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11400M

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the subject device is not available for evaluation, as it remains implanted in the patient.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

It was reported that a 31mm 11400m mitral valve in mitral position was disabled via valve in valve procedure after an implant duration of seven (7) days due to valve being "clotted off".Plan was to initially balloon the valve with hopes to resolve the issue, however, the physicians decided to implant a transcatheter valve.Tmvr was completed with a 29mm 9600tfx transcatheter valve, and patient was stable throughout the procedure.Patient was on ecmo during procedure.

Event Description

It was reported and learned through medical record that a 31mm 11400m mitral valve in mitral position was disabled via valve in valve procedure after an implant duration of seven (7) days due to thrombosed mitral valve, with severe stenosis and severely restricted leaflet motion.Salvage mitral balloon valvuloplasty and tmvr was completed with a 29mm 9600tfx transcatheter valve.Per medical records: the patient was initially seen in 2019 with severe ar, 2 vessel cad and normal ef.Subsequently, the patient readmitted several times over the next few years for advanced heart failure symptoms, patient with severe lv dysfunction, ef 30%, aortic root and ascending aorta dilated, thin and aneurysmal.Mitral valve with severe mr.The patient underwent cabg x3, aortic root bentall replacement using a 27mm konect, replacement of the ascending aorta with graft, chordal sparing mvr with 31mm mitris valve, iabp placement and placement of av ecmo.The patient was separated from cpb, the patient demonstrated poor baseline contractility despite moderate inotropic support, iabp was initially placed, hemodynamics remained labile, the iapb was removed, and the patient placed on a-v ecmo support.The patient transferred to the csu with stable hemodynamics.Post operative course was complicated by severe coagulopathy, bleeding, post cardiotomy pump failure, biventricular failure, vasoplegic and cardiogenic shock, aki on ckd, and metabolic acidosis.On pod #1 the patient underwent mediastinal exploration and evacuation of mediastinal hematoma, left pleural hematoma, right atrium and around the lateral aspect of the heart.Tee showed high mitral valve gradient, restricted motion of leaflets and possible thrombus.The patient not considered a candidate for revision of the mv.On pod #2 the patient underwent further mediastinal exploration, evacuation of clot and ecmo circuit exchange, a tee identified clot in the mitral annulus.Clot and mitral stenosis did not improve on heparin once coagulopathy improved.Echo on pod #4 on ecmo showed severe wall motion abnormalities, ef 15 to 20%.Mv severe stenosis, no mr, thrombus on valvular apparatus and leaflet motion severely restricted, aortic valve no as and no ar, normal leaflet excursion.On pod #7 the patient remained in cardiogenic shock with thrombosed mv, dependent on ecmo and underwent salvage balloon valvuloplasty followed by valve-in-valve procedure.An impella cp placed for cardiac support.The patient continued to decline, family requested withdrawal of life support and patient expired on pod #8.

Manufacturer Narrative

H11: additional manufacturer narrative: updated sections: b4, b5, b7, g3, g6, h4, h6 (component code, clinical code, device code, and type of investigation).

Manufacturer Narrative

A device history record (dhr) review is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.Engineering evaluation summary: thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots on the device/graft.There may be cases of incidental finding by imaging (ct scan) of thicken leaflets (halt) when the patient will benefit from a close follow-up and may be treated with oral anticoagulant.An engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling nonconformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.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 capa/scar/pra is not required as there is no confirmed product, or labeling non-conformances and no other triggers are met.It was reported that the patient was bleeding post-procedurally and was placed on ecmo.These might have contributed to formation of clots or thrombus.The most likely cause is patient factors.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: MITRIS RESLIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18991681
• MDR Text Key: 338885797
• Report Number: 2015691-2024-02390
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103205565
• UDI-Public: (01)00690103205565(17)270620(11)230621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• 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,Followup
• Report Date: 05/09/2024

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: 11400M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/01/2024; 05/08/2024
• Supplement Dates FDA Received: 04/29/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: 68 YR
• Patient Sex: Male