MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	2650
Medical Device Problem Codes	Degraded (1153); Gradient Increase (1270)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular regurgitation and/or stenosis.The subject device is not available for evaluation.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 or Problem Description
Edwards received notification that this 70-year-old patient with a porcine sav valve model 265025mm implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of 9 years and 11 months due to degeneration leading to stenosis.As reported, echo prior to valve in valve tavi ef 60-65.Ef 61, stenosis of prosthetic av 78/48, dvi.27, ava 1.03cm2.The patient presented with worsening heart failure which prompted reintervention.A 26mm sapien3 ultra valve was implanted within the surgical edwards valve using the transfemoral approach.Echo post pa pressures were normal with normal functioning of the aortic valve prosthesis.Well functioning tavi valve.Peak 26, mean 13.The patient was noted as discharged.
Additional Manufacturer Narrative
Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.In this case, minimal information regarding this procedure was received and attempts to obtain additional information regarding the condition of the device, patients medical history, or possible comorbidities have been made.No additional information was provided.Based on the available information, the progression of the patients underlying valvular disease pathology and comorbidities, combined with svd likely contributed to this event.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 or Problem Description
Edwards received notification that this 70-y-o patient with a porcine sav valve model 265025mm implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of 10 years and 8 months due to degeneration leading to stenosis.As reported, echo prior to valve in valve tavi ef 60-65.Ef 61, stenosis of prosthetic av 78/48, dvi.27, ava 1.03cm2.The patient presented with worsening heart failure which prompted reintervention.A 26mm sapien3 ultra valve was implanted within the surgical edwards valve using the transfemoral approach.Echo post pa pressures were normal with normal functioning of the aortic valve prosthesis.Well functioning tavi valve.Peak 26, mean 13.The patient was noted as discharged.

• Brand Name: CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 12929345
• Report Number: 2015691-2021-06675
• Device Sequence Number: 14877196
• Product Code: DYE
• UDI-Device Identifier: 00690103146899
• UDI-Public: 00690103146899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2022

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: 03/08/2010
• Device Model Number: 2650
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 01/13/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/10/2022; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2014
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 112 KG