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

Model Number	2800TFX
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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, may contribute to stenosis and/or regurgitation.Alternatively, the nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The subject device is not available for evaluation, as it remains implanted in the patient; therefore, the root cause for the stenosis and regurgitation remains indeterminable.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the 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
Through implant patient registry, it was reported that a patient with a 21mm 2800tfx aortic pericardial valve underwent a valve-in-valve procedure after an implant duration of four (4) years, seven (7) months due to severe aortic stenosis.The tavr was performed with a 23mm 9750tfx transcatheter valve successfully.The patient was discharged home on pod #1 in stable condition.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.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated h6 per new information received.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• 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
• MDR Report Key: 11283031
• Report Number: 2015691-2021-01122
• Device Sequence Number: 4279685
• Product Code: DYE
• UDI-Device Identifier: 00690103194081
• UDI-Public: (01)00690103194081(17)190517
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S02
• 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,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 2800TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR