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

Model Number	2800TFX23MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Through implant patient registry it was learned that a patient with a 23mm 2800tfx valve in the aortic position, was explanted after an implant duration of 4 years, 5 months due to unknown reason.The explanted valve was replaced with a 21mm 3300tfx valve.
Additional 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.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated: b4, b5, b7, g3, g6, h2, h6 based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
Through implant patient registry it was learned a 23mm 2800tfx aortic valve was explanted after an implant duration of four (4) years, five (5) months due to recurrent endocarditis.The explanted valve was replaced with a 21mm 3300tfx valve.Per medical records, patient had previously been hospitalized for bacteremia secondary to recurrent lle osteomyelitis (pseudomonas aeruginosa) on (b)(6) and was treated with iv antibiotics for many weeks.Patient was also found to have bilateral subacute cerebellar infarcts due to endocarditis.The patient underwent redo-avr with a 21mm 3300tfx valve.Post bypass tee showed no pvl.The patient was stable when transported to the intensive care unit and was discharged on pod#7.Pathology report confirmed vegetation, calcifications, and thrombosis.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: 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: 17809134
• Report Number: 2015691-2023-16140
• Device Sequence Number: 12558612
• Product Code: DYE
• UDI-Device Identifier: 00690103194098
• UDI-Public: (01)00690103194098(17)221103
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: 2800TFX23MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male