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

Model Number 300027MM

Device Problems Calcified (1077); Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Insufficient Information (3190); Device Stenosis (4066); Central Regurgitation (4068)

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

Event Date 11/17/2023

Event Type  Injury  

Event Description

Through implant patient registry it was learned that a 27mm 3000 valve in the aortic position, was explanted after an implant duration of 9 years, 6 months due to unknown reason.The explanted valve was replaced with a 23mm 3300tfx valve.

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.

Event Description

Through implant patient registry, it was learned that a 27mm 3000 valve in the aortic position, was explanted after an implant duration of 9 years, 6 months due to severe insufficiency, paravalvular leak, and moderate stenosis.The patient presented with doe.The explanted valve was replaced with a 23mm 3300tfx valve.Per medical records, the patient presented with doe and was admitted for acute hypoxic respiratory failure and stroke.The patient underwent redo sternotomy avr with a 23mm 3300tfx valve, mvr with a non-edwards valve and laa closure.The patient was taken to icu in satisfactory condition.Postoperative complication included av block with a permanent pacemaker implantation on pod #4.The patient also had positive blood cultures (staph epi) on pod #5 and was treated with iv antibiotics to rule out prosthetic valve endocarditis and/or cardiac device infection (2023-27300-02).Per pathology report identifies bioprosthetic av with leaflets that are tan-yellow to tan-red and focally moderately calcified.

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.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.H3: evaluation summary:report of insufficiency was confirmed due to condition of valve as received.Customer report of paravalvular leakage was unable to be confirmed through visual observations.Report of stenosis was confirmed through observed calcification.X-ray demonstrated wireform intact.Heavy calcification was observed on leaflets 2 and 3, and moderate calcification on leaflet 1.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 3 on the inflow aspect.Host tissue on the stent circumference was minimal at both the inflow and outflow aspects.Leaflet 1 had a 15mm long tear along commissure 2 and leaflet 2 had a 8mm long tear along commissure 2.Calcification was evident at the tears.Calcification restricted leaflet mobility and led to stenosis.As received, mechanical damage marks were observed on leaflet 2 at commissure 2 and leaflet 3 at commissures 1 and 3.Damages appeared serrated and did not penetrate leaflets.A suture thread and fastener remained attached to the sewing ring around leaflet 1.Wireform was exposed around all three leaflets.Sewing cloth was cut around leaflet 3 and exposed the metal band.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valves hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard 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 history of bicuspid aortic valve, diabetes mellitus, hyperlipidemia and atherosclerosis.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 regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Event Description

Through implant patient registry, it was learned that a 27mm 3000 valve in the aortic position, was explanted after an implant duration of 9 years, 6 months due to severe insufficiency, paravalvular leak, and moderate stenosis.The patient presented with doe.The explanted valve was replaced with a 23mm 3300tfx valve.Product eval observed heavy calcification on the leaflets.Per medical records, the patient presented with doe and was admitted for acute hypoxic respiratory failure and stroke.The patient underwent redo-avr with a 23mm 3300tfx valve, mvr with a non-edwards valve and laa closure.The patient was taken to icu in satisfactory condition.Postoperative complication included av block with a permanent pacemaker implantation on pod #4.The patient also had positive blood cultures (staph epi) on pod #5 and was treated with iv antibiotics to rule out prosthetic valve endocarditis and/or cardiac device infection (2023-27300-02).Per pathology report identifies bioprosthetic av with leaflets that are tan-yellow to tan-red and focally moderately calcified per product eval, report of stenosis was confirmed through observed calcification.Heavy calcification was observed on leaflets 2 and 3, and moderate calcification on leaflet 1 with minimal host tissue overgrowth.Calcification was evident at the leaflet tears.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18357640
• MDR Text Key: 330898085
• Report Number: 2015691-2023-18526
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

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: 10/15/2017
• Device Model Number: 300027MM
• 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: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 01/25/2024
• Supplement Dates FDA Received: 01/25/2024; 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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: 71 YR
• Patient Sex: Male