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

Model Number 3300TFX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Insufficient Information (4580)

Event Date 05/20/2023

Event Type  Death  

Event Description

Edwards implant patient registry received information a 27mm 3300tfx aortic valve was explanted after implant duration of four (4) years, one (1) month, due to unknown reasons.The explanted device was replaced with a 27mm 3300tfx aortic valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and 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.

Event Description

Through edwards implant patient registry and medical records, it was learned a 27mm 3300tfx aortic valve was explanted after implant duration of four (4) years, one (1) month, due to strep auginosus prosthetic valve endocarditis.The explanted device was replaced with a 27mm 3300tfx aortic valve.The patient tolerated procedure well and was transferred to icu in stable condition.Per medical records, blood cultures were positive with gpc in chains/strep auginosus.Patient was transferred from outside facility with endocarditis of the bioprosthetic aortic valve.Endocarditis of prostatic origin.Echocardiogram showed large mobile vegetation.The bioprosthetic valve was examined and multiple large vegetations were noted.These vegetations were removed and purulent fluid was encountered.The 27mm 3300tfx was explanted and replaced with another 27mm 3300tfx aortic valve.The patient tolerated the procedure well and was transferred to icu in stable condition.

Manufacturer Narrative

Added information to b5, b7, h6.The cause of the event was most likely due to patient factors.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• 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: 17232001
• MDR Text Key: 318176351
• Report Number: 2015691-2023-14265
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male