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

Model Number 6900PTFX

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 11/30/2022

Event Type  Injury  

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 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.

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.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b5, b7, h2, and h6.

Event 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 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
• Type of Device: 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
• MDR Text Key: 306066176
• Report Number: 2015691-2022-10285
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103163605
• UDI-Public: (01)00690103163605(17)240812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S22
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 6900PTFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/23/2022; 01/09/2023; 02/09/2023
• Supplement Dates FDA Received: 01/19/2023; 02/02/2023; 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male