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

Model Number 3300TFXJ

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The device was returned to edwards and is pending evaluation.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

It was reported that a patient with a 19mm 3300tfxj aortic pericardial valve was explanted after an implant duration of seven (7) years, one (1) month due to aortic stenosis and paravalvular leakage.The explanted valve was replaced with a 19mm 11500aj valve.Per the reported information, the patient was indicated for reoperation due to suspected aortic stenosis and regurgitation or paravalvular leakage.Preoperative echo could not distinguish between transvalvular regurgitation and paravalvular leakage.Upon the valve explant, the surgeon felt it was more likely to be paravalvular leakage.

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.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.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.Pannus can have both beneficial and harmful effects depending on the amount of growth.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed to the event.

Manufacturer Narrative

H3: customer report of paravalvular leakage was unable to be confirmed through visual observations.Report of stenosis was not confirmed.X-ray demonstrated wireform intact.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 3 on the inflow aspect and 2mm on leaflet 2 on the outflow aspect.Host tissue on the stent circumference was moderate at the inflow aspect and minimal at the outflow aspect.Multiple suture holes were visible on the sewing ring.Updated sections: g3, g6, h2, h3, h6 device code(s), and type of investigation.

• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17248116
• MDR Text Key: 318292412
• Report Number: 2015691-2023-14341
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S042
• 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
• Report Date: 08/31/2023

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: 06/12/2019
• Device Model Number: 3300TFXJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/18/2023; 08/15/2023
• Supplement Dates FDA Received: 08/14/2023; 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2015
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 81 KG