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

Model Number 3300TFX

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190); Thickening of Material (4056)

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

Event Type  Injury  

Event Description

It was reported that a patient with a 21mm 3300tfx aortic valve has been placed under evaluation/consideration for a valve-in-valve procedure after an implant duration of 9 years, 10 months due to unknown reason.

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.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

Updated sections: b5, d4 expiration date, g3, g6, h4, h6 investigation findings, and investigation conclusions.A device history record (dhr) review was not performed, as no information regarding a device failure mode was provided.Furthermore, 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.Despite multiple requests for additional information from the healthcare provider, no additional details have been provided.Based on the information available, a definitive root cause cannot be conclusively determined.

Event Description

It was reported that a patient with a 21mm 3300tfx aortic valve has been placed under evaluation/consideration for a valve-in-valve procedure after an implant duration of 9 years, 10 months due to unknown reason.Per additional information: the patient is still being evaluated at the clinic.

Event Description

It was reported and through investigation that a patient with a 21mm 3300tfx aortic valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of 9 years, 10 months due to leaflets appear thickened with restricted motion and severe stenosis suspect a component of ppm based on serial echoes.The patient presents with congestive heart failure nyha class 3.Per medical records, patient underwent pci/stent of rca.Tavr is recommended with goal of obtaining large orifice area, this would require surgical valve fracture (likely with true balloon) tee showed aortic leaflets appear thickened with restricted motion.Dobutamine stress echo reveal aortic valve mpg of 41mmhg.Echo showed aortic prosthesis appears well-seated and opens well, no regurgitation and mg 14.6mmhg.

Manufacturer Narrative

Updated sections: h6 component code, health effect - clinical code, device code(s), and type of investigation.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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: 18415035
• MDR Text Key: 331578181
• Report Number: 2015691-2023-18801
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S042
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2017
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2013
• 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): Other; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 86 KG