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

Model Number 3300TFX

Device Problem Perivalvular Leak (1457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  Injury  

Event Description

Edwards received notification that a 3300tfx25mm valve was explanted at implant from the aortic position due to paravalvular leak (pvl) [this report].A 23mm intuity elite valve was unsuccessfully attempted to be implanted.This second valve was also explanted at implant due the valve not correctly adhering to the annulus [reported under medwatch # 38568].Finally, a 23mm magna ease valve was successfully implanted in replacement.As reported, due to the prolonged surgery time, decision was made not to performed the planned treatment for the mitral insufficiency.The patient was transferred in stable condition to the hemodynamic room for coronary angiography study in consideration of the severe myocardial dysfunction at the right coronary artery area.Unfortunately, the patient died some time after procedure for unknown reason.

Manufacturer Narrative

H10: additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device and additional information is in process.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.

Manufacturer Narrative

H10: additional manufacturer narrative (corrected potential root cause): 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.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including patient fragile tissue caused by a previous endocarditis.

Manufacturer Narrative

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.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including hypercholesterolemia, excess calcification in the annulus at time of implant and insufficient debridement.

Manufacturer Narrative

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

Edwards received notification that a 3300tfx25mm valve was explanted at implant from the aortic position due to paravalvular leak (pvl) [this report].A 23mm intuity elite valve was unsuccessfully attempted to be implanted.This second valve was also explanted at implant due the valve not correctly adhering to the annulus [reported under medwatch (b)(4)].Finally, a 23mm magna ease valve was successfully implanted in replacement.Reportedly, both explants at implant were due to the patients fragile tissue caused by a previous endocarditis and not to a problem with the use of edwards devices.As reported, due to the prolonged surgery time, decision was made not to performed t the planned treatment in the mitral valve that presented mild regurgitation.The patient was transferred in stable condition to the hemodynamic room for coronary angiography study in consideration of the severe myocardial dysfunction at the right coronary artery area.Unfortunately, the patient died seven (7) days after procedure due to multiorgan failure.Per medical opinion, the prolonged intervention did not caused the patient death.Instead, the several comorbidities and the fragility of heart tissues due to endocarditis contributed to a serious injury in the patient.Additionally, it was confirmed that the use of edwards devices did not cause or contribute to the patients death.

• 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: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18102161
• MDR Text Key: 327737828
• Report Number: 2015691-2023-17352
• Device Sequence Number: 1
• Product Code: DYE
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2023

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: 3300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/11/2023; 12/22/2023; 12/22/2023
• Supplement Dates FDA Received: 12/05/2023; 12/22/2023; 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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): Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male