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

Model Number 7300TFX

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported a 27mm 7300tfx mitral valve implanted four (4) years, two (2) months, were explanted due to severe insufficiency and perivalvular leak (pvl).Per medical records, the patient presented with heart failure.Approximately six (6) months after implant of the 21mm 11500a aortic valve the patient was found on echo to have significant aortic insufficiency (pvl).Patient was somewhat short of breath but was able to be treated medically.Recent tee showed now new severe mitral regurgitation secondary to new pvl.Aortic valve was felt to still be severe aortic insufficiency and pvl.Patient underwent full sternotomy.There is a large pvl in the left sinus.The 27mm 7300tfx mitral valve was explanted and a 26mm 9755rsl transcatheter valve was attempted to be implanted; however, to positioning it was determined to remove and implant 25mm 11400m mitral valve.The patient also underwent re-do aortic valve replacement during the operation.Postprocedural tee revealed no pvl in mitral or aortic prosthesis with very good function.

Manufacturer Narrative

The device was not returned to edwards for evaluation and is not available.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The most likely cause is patient and procedural factors, including the combination of mac, sizing and seating of the valve.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18236810
• MDR Text Key: 329358844
• Report Number: 2015691-2023-17787
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103186260
• UDI-Public: (01)00690103186260(17)221204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S068
• 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: 01/23/2024

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 Expiration Date: 12/04/2022
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: 72 YR
• Patient Sex: Female