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

Model Number 3300TFX

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Dizziness (2194); Insufficient Information (4580)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

The device was explanted > 0 days for unknown reasons.Although there are multiple root causes, valves are typically explanted because they are not functioning optimally.The device was not returned for evaluation, as its availability is unknown.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 Description

Through implant patient registry it was learned that a 21mm aortic valve was explanted after an implant duration of 3 years, 8 months due to unknown reason.The explanted valve was replaced with a 23mm valve.The patient was in recovery post procedure.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.

Event Description

Through implant patient registry it was learned that a 21mm aortic valve was explanted after an implant duration of 3 years, 8 months due to moderate perivalvular leak and severe regurgitation.The patient presented with sob and dizziness.The explanted valve was replaced with a 23mm valve.Per medical records the patient underwent redo-avr, mvr with 29mm non-edwards valve, and repair of ascending aortic dissection with a graft.The post operative tee revealed normally functioning bioprosthetic aortic and mitral valves without pvl.The patient was discharged on pod #14.

Manufacturer Narrative

Regurgitation/insufficiency of prosthetic valves may be caused by many different root causes.Surgical/percutaneous intervention may be indicated or required.

Manufacturer Narrative

The most likely cause is patient factors, including coronary artery disease (cad) and the significant scarring found during re-do avr.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 MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: 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 ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15832178
• MDR Text Key: 303995912
• Report Number: 2015691-2022-09377
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176131
• UDI-Public: (01)00690103176131(17)221022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 3300TFX
• Device Catalogue Number: 3300TFX21MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 12/21/2022
• Supplement Dates FDA Received: 12/13/2022; 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• 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: 82 YR
• Patient Sex: Male