MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SEE H10; TISSUE, HEART-VALVE

Model Number 8300ACD25

Device Problems Calcified (1077); Structural Problem (2506)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Failure of Implant (1924)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

This model is not sold or marketed in the u.S.However, it is similar to device: model #8300ab; brand name: edwards intuity elite valve system; pma #p150036.Attempts to obtain additional information and for product return has been made.The subject device has not been returned for evaluation.There is currently insufficient information to determine the root cause of this event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that this clinical trial patient had a 25mm pericardial aortic valve explanted after an implant duration of three (3) years and nine (9) months due to severe calcification leading to severe aortic stenosis and aortic insufficiency.The explanted valve was replaced with a 23mm non-edwards surgical valve.It was also noted that cabg x2 was performed.The patient was noted as recovering in the icu post-procedure.

Manufacturer Narrative

The explanted valve has been returned for evaluation; however, the analysis is still in progress.A supplemental report will be submitted accordingly once the product evaluation has been completed.

Event Description

The patient was discharged home on pod #9 in stable condition.

Manufacturer Narrative

Evaluation summary: customer report of calcification was confirmed.As received, all three leaflets were cut out from the valve.The cuts had smooth and even edges.X-ray demonstrated heavy calcification on one leaflet, and moderate calcification on the other two leaflets.The wireform was observed to be distorted, and commissure 1 was bent.Host tissue on the stent circumference was heavy at the inflow and moderate at the outflow aspect.The observed calcification likely contributed to the reported stenosis.However, stenosis and insufficiency could not be confirmed due to condition of the valve as received.The sewing ring was cut around commissure 3.The wireform was exposed around leaflet 3, on commissure 2, and on the side of the valve near commissures 1 and 3.Calcification plays a major role in the failure of bioprosthetic heart valves.Calcification of valves occurs as a progressive, time-dependent process.Tissue valve calcification is initiated primarily within residual cells that have been devitalized.Initial calcification deposits eventually enlarge and grow into a mass, which stiffen and weaken the tissue and thereby cause the prosthesis to malfunction.The mineralization of a biomaterial is generally enhanced at the sites of intense mechanical deformations generated by motion, such as the points of flexion in heart valves.Ultimately, the result of calcification is valve failure due to tearing or stenosis.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 valve's 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 bioprosthesis from calcifying.It is not common for a bioprosthetic heart valve to be develop an early calcification related svd that is severe enough to be explanted.In this case, a definitive root cause for calcification after an implant duration of three (3) years nine (9) months could not be conclusively determined.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SEE H10
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7719417
• MDR Text Key: 115060447
• Report Number: 2015691-2018-03010
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2015
• Device Model Number: 8300ACD25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 88