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)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

H10.Additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device 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 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 valve model 3300tfx25mm was explanted from the aortic position after an implant duration of approximately three (3) years and five (5) months due to transvalvular regurgitation observed preoperatively on transoesophageal echocardiography (toe).As reported, upon examination of the valve, the source of the leak could not be identified.

Manufacturer Narrative

H10.Additional manufacturer narrative: further information was received regarding the patient demographics, serial number and device availability.Due to some issues with the courier collecting the device, no sample for evaluation was received, therefore no product evaluation of the device could be performed by edwards.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.

Event Description

Edwards received notification that a valve model 3300tfx25mm was explanted from the aortic position after an implant duration of approximately three (3) years and eleven (11) months due to transvalvular regurgitation observed preoperatively on transoesophageal echocardiography (toe).As reported, upon examination of the valve, the source of the leak could not be identified.A valve model 3300tfx23mm was implanted in replacement.

Manufacturer Narrative

Updated: b5 (describe event or problem), b6 (relevant tests/laboratory data, including dates), b7 (other relevant history), d9 (device availability), h3 (device evaluated by manufacturer), h6 (clinical code), h6 (type of investigation).Added: h6 (device code).Further information was received through investigation, and the device was also sent to our product evaluation laboratory for a full evaluation.Customer report of regurgitation could not be confirmed through visual observations.X-ray demonstrated wireform intact and a calcification nodule on the host tissue overgrowth encroaching over leaflet 1 on the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2 millimeters on leaflet 1 at the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3 millimeters on leaflet 1 at the outflow aspect.Host tissue overgrowth on the stent circumference was minimal at the outflow and inflow aspect.Sewing ring was cut off around the valve and fragments of the sewing ring were returned.The metal band was exposed around the inflow aspect of the valve due to the cut sewing ring.No visible inconsistencies were observed on the valve.

Event Description

Edwards received notification that a valve model 3300tfx25mm was explanted from the aortic position after an implant duration of approximately three (3) years and eleven (11) months due to significant transvalvular regurgitation and mild to moderate paravalvular regurgitation observed preoperatively on transoesophageal echocardiography (toe).Reportedly, the leaflets appeared normal, thus the root cause of the regurgitation was unknown.As reported, upon examination of the valve, the source of the leak could not be identified.The patient presented with heart failure.A new valve was successfully implanted in replacement.The patient was noted as to be well and discharged home on post operative day 7.The explanted device was noted to be available for return.

Event Description

Edwards received notification that a valve model 3300tfx25mm was explanted from the aortic position after an implant duration of approximately three (3) years and eleven (11) months due to severe transvalvular regurgitation and mild to moderate paravalvular regurgitation observed preoperatively on transoesophageal echocardiography (toe).Reportedly, the leaflets appeared normal, thus the root cause of the regurgitation was unknown.As reported, upon examination of the valve, the source of the leak could not be identified.The patient presented with heart failure.A new surgical valve was successfully implanted in replacement.The patient was noted as to be well and discharged home on post operative day 7.

Manufacturer Narrative

H10: additional 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.

Manufacturer Narrative

Added information to section h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) corrected data h6 (component code): "439 - cusp/leaflet" code removed.H3: evaluation summary: complaint of severe transvalvular regurgitation and mild to moderate paravalvular regurgitation was unable to be confirmed.Customer report of regurgitation could not be confirmed through visual observations.X-ray demonstrated wireform intact and a calcification nodule on the host tissue overgrowth encroaching over leaflet 1 on the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 1 at the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 1 at the outflow aspect.Host tissue overgrowth on the stent circumference was minimal at the outflow and inflow aspect.Sewing ring was cut off around the valve and fragments of the sewing ring were returned.The metal band was exposed around the inflow aspect of the valve due to the cut sewing ring.No other visible inconsistencies were observed on the valve.The sewing ring was completely removed from the valve.In the condition received, functional testing could not be performed.The observations seen from in vitro may be different from those obtained in vivo due to hemodynamic and environmental differences experienced while implanted, which were not present when the valve was returned to edwards h10: additional manufacturer narrative: 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.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.It is possible that mechanical stresses on the valve also contributed to the reported transvalvular leakage.Based on the information available, a definitive root cause was unable to be determined.

• 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: 17244840
• MDR Text Key: 318284984
• Report Number: 2015691-2023-14336
• 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,Followup
• Report Date: 12/15/2023

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 Expiration Date: 04/09/2023
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/14/2023; 08/23/2023; 10/02/2023; 11/22/2023
• Supplement Dates FDA Received: 08/09/2023; 09/22/2023; 10/17/2023; 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male