MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART-VALVE

Device Problems Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 07/13/2023

Event Type  Injury  

Event Description

Edwards received notification that a 83 year old patient with a 25mm edwards margna valve implanted in unknown position, underwent a valve-in-valve after procedure an implant duration of more or less 10 years for unknown reason.A 26mm transcatheter valve was successfully implanted within the pre-existing edwards surgical device.

Manufacturer Narrative

H10: additional manufacturer narrative: the subject device is not available for evaluation as it remains implanted in the patient.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

H10: additional manufacturer narrative: the serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The device was not returned for evaluation as it remained implanted after the valve-in-valve (viv) procedure, therefore customer report of calcification could not be confirmed by product evaluation.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 implant duration over 10 years and dyslipidemia.Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots forming on the device/graft.These clots could significantly impact the function of the valve resulting in harm.There may be cases of incidental finding by imaging (echocardiography and/or ct scan) of subclinical leaflet thrombosis (halt) where the patient will benefit from a close follow-up and may be treated with oral anticoagulant.The most likely cause is patient factors.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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Manufacturer Narrative

Added: a2 (date of birth), e1 (contact information) updated: b5 (describe event or problem), b7 (other relevant history, including preexisting medical conditions (e.G allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.))), h6 (impact code, clinical code, device code).E1 reporter name: dimytri siquiera and jose victor francisco.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.

Event Description

Edwards received notification that a 83 years old patient with a 25mm edwards magna valve implanted in mitral position, underwent a valve-in-valve procedure after an implant duration of more than 10 years due to calcification and thrombosis leading to stenosis and moderate to severe periprosthetic leak.As reported, the patient was diagnosed with valve thrombosis 4 months before the reintervention.Thus, her anticoagulation medication was changed but no significant improvement was observed.As the symptoms persisted, a valve-in-valve was performed.Concomitantly, a vascular plug was placed to solve the perivalvular leak.The patient presented with dyspnea.A 26mm transcatheter valve was successfully implanted within the pre-existing edwards surgical device.As reported, patient was noted as to be discharged home.

• Brand Name: NI
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; mle fl2- office m2013; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17452377
• MDR Text Key: 320368564
• Report Number: 2015691-2023-15012
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 09/15/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 09/12/2023
• Supplement Dates FDA Received: 09/08/2023; 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female