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

Model Number	6900PTFX
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available for evaluation, as it was discarded on-site.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
It was learned from implant patient registry that a model 6900ptfx 29mm mitral valve was explanted and replaced with a 6900ptfx 31mm valve after an implant duration of 1 year, 6 months due to unknown reasons.The patient was in recovery post operation.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
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.Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Valve dehiscence is not a malfunction of the device.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b5, b7, h2, and h6.
Event or Problem Description
It was also learned from implant patient registry that a model 6900ptfx 29mm mitral valve was explanted and replaced with a 6900ptfx 31mm valve after an implant duration of 1 year, 6 months due to severe mitral valve insufficiency and severe perivalvular dehiscence and stenosis.The patient presented with shortness of breath.The patient was in recovery post operation.
Event or Problem Description
It was also learned from implant patient registry that a model 6900ptfx 29mm mitral valve was explanted and replaced with a 6900ptfx 31mm valve after an implant duration of 1 year, 6 months due to severe mitral valve insufficiency and severe perivalvular dehiscence and stenosis.The patient presented with shortness of breath.The patient was in recovery post operation.Per the medical records, the patient presented with rocking mitral prosthesis, severe mitral valve pvl where it juxtaposed to the aortic valve and pulmonary htn.The patient is referred for redo valve replacement surgery.The 11500a 23mm aortic valve was explanted and replaced with a 11500a 25mm valve and the 6900ptfx 29mm mitral valve was explanted and replaced with a 6900ptfx 31mm valve.The mitral curtain and lvot were reconstructed and enlarged with a patch in a commando approach as the mv and av were in very close proximity to the region of the large perivalvular dehiscence.The aortic root was enlarged.Post operation echo demonstrates well seated aortic and mitral valve without perivalvular leak.The patient tolerated the procedure well with no apparent complications, transported to intensive care unit in intubated, stable condition.

• 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; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16036296
• Report Number: 2015691-2022-10285
• Device Sequence Number: 17550255
• Product Code: DYE
• UDI-Device Identifier: 00690103163605
• UDI-Public: (01)00690103163605(17)240812
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S22
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2023

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 Expiration Date: 08/12/2024
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 01/09/2023; 02/09/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/19/2023; 02/02/2023; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• 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: 57 YR
• Patient Sex: Male