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

Model Number 7300TFX25

Device Problems Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiogenic Shock (2262); Thrombosis/Thrombus (4440)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that a patient with an 25mm 7300tfx, underwent a valve-in-valve procedure after an implant duration of 11 days due to iatrogenic mitral stenosis with possible thrombus on the valve.The tmvr was performed with a 26mm 9750tfx transcatheter valve.Per medical records, patient initially underwent an mvr due to severe native mr with a 25mm mitral ease valve.The patient later underwent valve-in-valve procedure with a 26mm s3 valve.Intraoperatively, the previously noted laa was no longer demonstrated.

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.

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.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

Event Description

It was reported that a patient with an 25mm 7300tfx, underwent a valve-in-valve procedure after an implant duration of 5 days due to iatrogenic mitral stenosis.The tmvr was performed with a 26mm 9750tfx transcatheter valve.Per medical records, patient initially underwent mvr ((b)(6) 2023) and later presented with cardiogenic shock, dic with ecmo and impella devices placed, and developed profound gradient over the next two days which improved on heparin drip.On pod#2 there was no obvious thrombosis or mechanical impingement of the leaflets.On pod#5, mitral gradient was 30mmhg with left atrial appendage (laa) thrombus.The patient later underwent valve-in-valve procedure with a 26mm s3 valve.Intraoperatively, the previously noted laa was no longer demonstrated.

Manufacturer Narrative

The subject device was not returned for evaluation as it was remains implanted within the patient and no pictures of the device were provided for evaluation.Medical records were, however, provided for review, confirming the reported iatrogenic mitral stenosis.A dhr review was performed and no relevant non-conformances were identified.The complaint was was confirmed through medical records.There is no evidence to suggest an edwards/supplier manufacturing defect.Based on the limited information available, the complaint is confirmed and the most likely cause is due to patient factors, including a blood clot that contributed with the early mitral stenosis.An edwards defect has not been confirmed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• 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: 18248187
• MDR Text Key: 329501445
• Report Number: 2015691-2023-17852
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7300TFX25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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: 63 YR
• Patient Sex: Female