MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SEE H10; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11400M27

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2022

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 received information that a 27mm 11400m mitral pericardial valve was explanted on postoperative day three (3) due to an interference with the patient's native chordae tendineae.The device was originally implanted for mitral valve replacement to correct mitral stenosis.The device was explanted and replaced with a smaller size same model 25mm 11400m.The patient status was reported as "under treatment".The device was not returned for evaluation as it was discarded at the hospital.There was no allegation of device malfunction.Multiple cardiac surgical procedure: tricuspid annuloplasty with a 28 mm 6200t ring at implant.The doctor was asked and has affirmed that there was no malfunction of the device and the device did not cause or contribute to the event.The doctor commented that this event was caused by the patient's anatomy and technical factors.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Dhr review was performed and no relevant nonconformances were identified.The doctor was asked and has affirmed that there was no malfunction of the device and the device did not cause or contribute to the event.Based on the available information, the cause of the event is patient and procedural factors.

• Brand Name: SEE H10
• 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 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13744557
• MDR Text Key: 291295671
• Report Number: 2015691-2022-04408
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103205541
• UDI-Public: (01)00690103205541(17)230205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S06
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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 Expiration Date: 02/05/2023
• Device Model Number: 11400M27
• Device Catalogue Number: 11400M27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/12/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/13/2022
• Date Device Manufactured: 02/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening