MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300A

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Patient-Device Incompatibility (2682)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Citation: van praet km, nersesian g, kukucka m, heil e, kofler m, falk v, klein c, kempfert j, unbehaun a.Transcatheter aortic valve-in-valve implantation under cerebral protection in a patient with a deteriorated 19-mm rapid-deployment bioprosthetic valve.Multimed man cardiothorac surg.2022 apr 1;2022.Doi: 10.1510/mmcts.2022.014.Pmid: 35377972.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.

Event Description

Through review of a video/case presentation: transcatheter aortic valve-in-valve implantation under cerebral protection in a patient with a deteriorated 19-mm rapid-deployment bioprosthetic valve, the following event was identified as pertaining to an edwards device: a 81-years-old female patient with a valve model 8300a19 implanted in aortic position underwent a valve-in-valve procedure after an implant duration of approximately eight (8) years and five (5) months due to structural valve degeneration leading to simultaneous severe aortic stenosis (myocardial perfusion grade [mpg] 42 mmhg, aortic valve opening area 0.82 cm2, peak jet velocity 4.2 m/s), and moderate aortic regurgitation (vena contracta width 0.4 cm, regurgitant volume 44 ml, effective regurgitant orifice area 0.19 cm2).Preexisting patient prosthesis mismatch was also detected (bmi 30kg/m2; bsa 1,89m2; mean pressure gradient of 24mmhg two months after the initial procedure).The patient presented with nyha class iii and severe dyspnea at rest for two months prior to the procedure.Transesophageal echocardiographic (tee) revealed valve degeneration.A 23mm non-edwards valve was successfully implanted within the surgical device.The patient was discharged home 4 days after procedure in an improved physical condition.

Manufacturer Narrative

Added: h6 (type of investigation).Corrected b5 (describe event or problem).Updated: b4, g3 (date received by manufacturer), g6, h2, h6 (investigation findings, investigation conclusions).The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration 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 a history of non-insulin dependent diabetes mellitus, dyslipidemia and peripheral artery disease.Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Event Description

Through review of a video/case presentation: transcatheter aortic valve-in-valve implantation under cerebral protection in a patient with a deteriorated 19-mm rapid-deployment bioprosthetic valve, the following event was identified as pertaining to an edwards device: a 81-year-old female patient with a valve model 8300a19 implanted in aortic position underwent a valve-in-valve procedure after an implant duration of approximately eight (8) years and five (5) months due to structural valve degeneration leading to simultaneous severe aortic stenosis (myocardial perfusion grade (mpg) 42 mmhg, aortic valve opening area 0.82 cm2, peak jet velocity 4.2 m/s), and moderate aortic regurgitation (vena contracta width 0.4 cm, regurgitant volume 44 ml, effective regurgitant orifice area 0.19 cm2) apart from preexisting patient prosthesis mismatch (bmi 30kg/m2; bsa 1,89m2; mean pressure gradient of 24mmhg two months after the initial procedure).The patient presented with nyha class iii and severe dyspnea at rest.Transesophageal echocardiographic (tee) revealed valve degeneration.Doppler image showed a regurgitant jet in the left ventricle orifice outflow track (lvot) and an orifice area of 0.97cm2.As per surgeon's assessment during the procedure, "we are facing some kind of ppm in this patient but the main problem is deterioration of the bioprosthesis.The patient did very fine for many years and suddenly a couple of month ago she became symptomatic".A 23mm non-edwards valve was successfully implanted within the surgical device device followed by a balloon valvuloplasty to fracture the initial surgical valve.No ppm or pvl were observed post-op.Patient was discharged home on pod # 4 in an improved physical condition.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 16563223
• MDR Text Key: 311481017
• Report Number: 2015691-2023-11537
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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 Model Number: 8300A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/21/2023
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Female