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); Sepsis (2067); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device and additional information are 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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards lifesciences maintains an implant patient registry (ipr).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.It was reported via the implant patient registry that this valve model 3300tfx23mm implanted in aortic position was explanted from a 73 year old patient after an implant duration no longer than six (6) months and two (2) days for unknown reason.A 21mm surgical aortic valve was implanted in replacement.

Event Description

It was reported via the implant patient registry that this valve model 3300tfx23mm implanted in aortic position was explanted from a 73 year old patient after an implant duration of four (4) months and three (3) days due to endocarditis leading to annular abscess.The infecting organism was mssa (meticillin-sensitive staphylococcus aureus).Reportedly, the patient had cellulitis after electromyography (emg) and presented with sepsis.A 21mm surgical aortic valve was implanted in replacement.The patient was noted as to be discharged home.

Manufacturer Narrative

Added information to section d6 (explanted date).Updated section b4 (date of this report), b5 (describe event or problem), g3 (date received by manufacturer), h6 (device code(s)) and h6 (health effect - clinical code), h6 (investigation findings) and h6 (investigations conclusions).Corrected h6 (device code(s)) and h6 (health effect - clinical code).H10: additional manufacturer narrative: corrected data: initially, it was reported via the implant patient registry that this valve model 3300tfx23mm implanted in aortic position was explanted from a 73 year old patient after an implant duration no longer than six (6) months and two (2) days for unknown reason.A 21mm surgical aortic valve was implanted in replacement.However, through investigation it was learned that the valve was explanted from this patient after an implant duration of 4 months and 3 days due to endocarditis leading to annular abscess.Reportedly, the patient had cellulitis after electromyography (emg) and presented with sepsis.A valve model 3300tfx21mm was successfully implanted in replacement.The patient was noted as to be discharged home.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 ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18099344
• MDR Text Key: 327699081
• Report Number: 2015691-2023-17336
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 12/11/2023
• 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: 73 YR
• Patient Sex: Male