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

Model Number 7300TFX

Device Problems Calcified (1077); Gradient Increase (1270); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

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

Event Date 06/14/2023

Event Type  Injury  

Event Description

Edwards received notification, that this valve model 7300tfx27mm was explanted from the mitral position.After an implant duration of three (3) years and nine (9) months, due to lvot (left ventricular outflow tract) obstruction caused by one of the struts and pannus overgrowth.As reported, the valve seemed to be appropriately oriented.Additionally, one leaflet was also completely calcified.This event involved a 79-year-old patient.Reportedly, at the initial implant, the patient left the or with a lvot gradient of 15mmhg.The physician used an intra-annular implantation technique and put pledgets on the right atrium side.Before the reoperation, her lvot gradient was up to 90mmhg.A non-edwards valve was implanted in replacement.A septal myomectomy was performed concomitantly to increase the room in the lvot.

Manufacturer Narrative

H3: product evaluation: customer report of calcification and pannus were confirmed.Report of lvot obstruction was unable to be confirmed through visual observations.The x-ray demonstrated moderate calcification on leaflets 1 and 2, heavy calcification on leaflet 3, and wireform intact.Extrinsic calcific deposits were observed on the outflow surface of leaflets 1 and 2 near commissure 2.Moderate host tissue overgrowth encroached onto the tissue and into the orifice on leaflet 2 at the outflow aspect.Host tissue overgrowth and calcification fused leaflets 1 and 2 at commissure 2 on the outflow aspect.Host tissue overgrowth fused leaflets 2 and 3 at commissure 3 on the outflow aspect.Host tissue on the stent circumference was minimal at both the inflow and outflow aspects.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Sewing cloth of sewing ring was cut around leaflet 2.Multiple suture holes were visible around the sewing ring.See attached evaluation photos.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 b5 (describe event or problem) and b7 (other relevant history, including preexisting medical conditions (e.G allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)) updated section h6 (health effect - clinical code).

Event Description

Edwards received notification that this valve model 7300tfx27mm was explanted from the mitral position after an implant duration of three (3) years and nine (9) months due to lvot (left ventricular outflow tract) obstruction caused by one of the struts and pannus overgrowth.As reported, the valve seemed to be appropriately oriented.Additionally, one leaflet was also completely calcified.This event involved a 79 years old patient.Reportedly, at the initial implant, the patient left the or with a lvot gradient of 15mmhg.The physician used an intra-annular implantation technique and put pledgets on the right atrium side.Before the reoperation, her lvot gradient was up to 90mmhg and mitral valve gradient was 8mmhg.The patient presented with severe shortness of breath.A non-edwards valve was implanted in replacement.A septal myomectomy was performed concomitantly to increase the room in the lvot.The patient was noted as to be discharged to regional hospital.

Manufacturer Narrative

Added information to section d4 (expiration date), h4 (device manufacturer date), h6 (device code(s)), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).Corrected data h6 (device code(s)): 2423 - obstruction of flow (code removed).H10: additional manufacturer narrative: the device history record (dhr) 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.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.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.Host fibrous (pannus) tissue growth is not a malfunction of the device.The most likely cause is patient factors.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 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 bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including dyslipidemia, severe chronic renal failure and non-insulin dependent diabetes.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL 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: 17323020
• MDR Text Key: 319015060
• Report Number: 2015691-2023-14560
• 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
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female