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

Model Number 11400M

Device Problem Insufficient Information (3190)

Patient Problems Pseudoaneurysm (2605); Insufficient Information (4580)

Event Date 08/07/2023

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

Through implant patient registry it was learned that a 29mm 11400m valve in the mitral position, was explanted after an implant duration of 1 month, 25 days due to unknown reason.The explanted valve was replaced with another 29mm 11400m valve.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, b5, b7, d9, g3, g6, h2, h3, h6 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

Through implant patient registry it was learned that a 29mm 11400m valve in the mitral position, was explanted after an implant duration of 1 month, 25 days to repair lv pseudoaneurysm.The explanted valve was replaced with another 29mm 11400m valve.Per medical records, the patient presented with afib rvr, with hit and dvt on rle.Preopertative workup showed noted large lv pseudoaneurysm with valvular dehiscence.The patient underwent a re-do mvr with a 29mm 11400m valve and patch closure of the posterior lv pseudoaneurysm.Post bypass tee revealed mv functioned well with no insufficiency and no other valvular abnormalities.The patient was transferred back to his room in good condition.

Manufacturer Narrative

On occasion the device may be explanted with no evidence of malfunction and is otherwise performing as intended.Such as for aortic graft replacement, to enlarge aortic root, repair fistula, control bleeding/coagulopathy or other non-device related reason.In these events, the device may require removal to control bleeding or to facilitate repair of the injury.The event is not related to the device and therefore is not considered serious injury.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 it was learned that a 29mm 11400m valve in the mitral position, was explanted after an implant duration of 1 month, 25 days to repair lv pseudoaneurysm.The explanted valve was replaced with another 29mm 11400m valve.Per medical records, the patient presented with afib rvr, with hit and dvt on rle.Preoperative workup showed noted large lv pseudoaneurysm with valvular dehiscence.The patient underwent a re-do mvr with a 29mm 11400m valve and patch closure of the posterior lv pseudoaneurysm.Post bypass tee revealed mv functioned well with no insufficiency and no other valvular abnormalities.The patient was transferred back to his room in good condition.Per product eval, there was minimal host tissue observed.

Manufacturer Narrative

The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.H3 summary: customer report of lv pseudoaneurysm repair was unable to be confirmed through visual observations.X-ray demonstrated wireform intact.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 2 at the inflow aspect.Host tissue overgrowth on the stent circumference was minimal at the outflow aspect.Sewing ring cloth was cut in multiple areas around the valve.No other visible inconsistencies were observed on the valve.

Event Description

Through implant patient registry it was learned that a 29mm 11400m valve in the mitral position, was explanted after an implant duration of 1 month, 25 days to repair lv pseudoaneurysm.The explanted valve was replaced with another 29mm 11400m valve.Per medical records, the patient presented with afib rvr, with hit and dvt on rle.Tee prior to valve explant showed large lv pseudoaneurysm and prosthetic mitral valve functioning well with no other valvular abnormalities.The patient underwent a re-do mvr with a 29mm 11400m valve and patch closure of the posterior lv pseudoaneurysm.The prosthetic mv was lifted out showing a larger sized posterior pseudoaneurysm requiring a patch.The valve was replaced with another 29mm 11400m valve.Post bypass tee revealed mv functioned well with no insufficiency and no other valvular abnormalities.The patient was transferred back to his room in good condition.Per product eval, there was minimal host tissue observed.

Manufacturer Narrative

H10: additional manufacturer narrative: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EDWARDS MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine 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: 17652201
• MDR Text Key: 322307085
• Report Number: 2015691-2023-15579
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)270410(11)2304112110381853
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male