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

Model Number	6900PTFX
Medical Device Problem Codes	Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received information a patient with a 27mm 6900ptfx mitral valve implanted five (5) years, 11 months, underwent attempted valve-in-valve procedure due to stenosis.Two 26mm 9750tfx transcatheter valves were attempted to be implanted inside the 27mm surgical valve without success.Case was aborted.Re-do mitral valve replacement is being considered at a later date.
Additional 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.
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.
Event or Problem Description
Edwards received information a patient with a 27mm 6900ptfx mitral valve implanted five (5) years, 11 months, underwent attempted valve-in-valve procedure due to stenosis.Two 26mm 9750tfx transcatheter valves were attempted to be implanted inside the 27mm surgical valve without success.Case was aborted.The patient underwent successful valve-in-valve procedure after a 27mm 6900ptfx mitral valve implant duration of six (6) years, one (1) month.A 29mm 9600tfx was implanted inside the 27mm valve.
Additional Manufacturer Narrative
H10.Additional manufacturer narrative: added information to a1, a2, a3, b5, b7, d1, d4, h4, h6.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.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Svd, a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The cause of the event cannot be determined; however, patient factors and progression of underlying valvular disease may have contributed to the event.
Event or Problem Description
Edwards received information a patient with a 27mm 6900ptfx mitral valve implanted six (6) years one (1) month, underwent attempted valve-in-valve procedure due to stenosis.Two 26mm 9750tfx transcatheter valves were attempted to be implanted inside the 27mm surgical valve without success.Case was aborted.Attempts to retrieve additional information was unsuccessful.
Event or Problem Description
Edwards received information a patient with a 27mm 6900ptfx mitral valve implanted for 2 years developed enterococcus faecalis endocarditis.(4) years, one (1) month later the patient underwent valve-in-valve procedure due to severe degenerative symptomatic mitral stenosis and regurgitation secondary to endocarditis.A 26mm s3 ultra transcatheter valve was implanted inside the 27mm valve.The patient tolerated the procedure well and was transferred to recovery room in stable condition.Per medical records, approximately 2 months earlier the patient had initially underwent attempted tmvr valve-in-valve procedure with a 29mm s3.However due to hostile septal anatomy the procedure was aborted.The patient presented with acute on chronic diastolic heart failure.The patient was then re-evaluated and decision was made to proceed with valve-in-valve using a 26 s3.
Additional Manufacturer Narrative
The cause of the event was most likely due to patient factors/conditions.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13830724
• Report Number: 2015691-2022-04518
• Device Sequence Number: 13783632
• Product Code: DYE
• UDI-Device Identifier: 00690103163629
• UDI-Public: (01)00690103163629(17)190621
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/08/2022

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 Expiration Date: 06/21/2019
• Device Model Number: 6900PTFX
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 05/03/2022; 05/05/2022; 07/08/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 05/08/2022; 05/31/2022; 07/08/2022
• Date Device Manufactured: 06/22/2015
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female