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

Model Number 8300AB25

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Cardiogenic Shock (2262); Cusp Tear (2656); No Code Available (3191)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: customer report of valve detachment could not be confirmed through visual observation.As received, valve had a pinkish hue.Minimal host tissue overgrowth was observed on frame and stent circumference.X-ray demonstrated frame expanded and slightly pushed in below commissure 3.As received, leaflet 2 was in a partially opened position.Open leaflet was able to be pushed back into closed position when probed.X-ray also demonstrated wireform intact.A straight and even cut, measuring approximately 4 mm, was observed on the free margin of leaflet 2 and was partially non-transmural.Leaflet 3 was observed to have a serrated mechanical damage.Suture holes were not visible at the black stitch markings due to host tissue overgrowth; one green suture remained attached at black stitch marking near leaflet 1.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.Ppm has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.The root cause of this event was likely due to procedural related factors.There is no information suggesting there was any malfunction or deficiency of the edwards valve.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.

Event Description

Edwards received notification that a 25mm aortic pericardial valve was explanted after an implant duration of three (3) months due to valve detachment causing the valve to migrate into the ventricle.According to surgeon's opinion, "there was a valve mismatch".The valve was too big.This caused an oblique implant and after three (3) months, there was partial detachment of two (2) sutures, the valve went ventricular with partial rupture of anterior mitral leaflet.A 23mm 11500a aortic valve was implanted in replacement.At the time of the reported event, the patient was noted to be in the intensive care unit with a good prognosis.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Manufacturer Narrative

H10: additional narratives: updated b2, b5, and h6 per new information rerceived.

Event Description

Edwards received notification that an elite valve model 8300ab25 was explanted from the aortic position after an implant duration of 3 months due to valve detachment causing a complete dislocation of the valve that remained anchored to the annulus only by one of the three suture points, the one placed on the right coronary commissure.Reportedly, the implantation of the intuity prosthesis, was not contraindicated and its size was also congruous (neither over- nor under-sized) with the native aortic valve ring given excellent immediate result.During index procedure the calcium was carefully removed.The immediate post operative transesophageal echocardiography showed that the valve was correctly implanted without the presence of leaks.As reported, 7 days after procedure, a double mild to moderate paravalvular regurgitation was observed on echo.Another echo performed 10 days later confirmed the two periprosthetic leaks that were unchanged.The patient was discharged home.However, 3 months after implant, the patient was hospitalized for a cardiogenic shock and pericardiac arrest.Reportedly, the valve dislocation had caused a partial rupture of anterior mitral leaflet leading to massive mitral insufficiency.An inspiris resilia valve model 11500a23 was implanted in replacement.At the time of the reported event the patient was noted as to be in the intensive care unit with a good prognosis.However, from new information provided, the patient had a severe multi organ failure in the post operative period with acute hepatitis and renal failure with anuria and the need for dialysis and the patient died 23 days later.Cause of death was multiorgan failure, severe hf / ef at 35 % with severe hypokinesia and hepatorenal failure.

Event Description

Edwards received notification that an elite valve model 8300ab25 was explanted from the aortic position after an implant duration of 3 months due to valve detachment causing a complete dislocation of the valve that remained anchored to the annulus only by one of the three suture points, the one placed on the right coronary commissure.Reportedly, the implantation of the intuity prosthesis, was not contraindicated and its size was also congruous (neither over- nor under-sized) with the native aortic valve ring given excellent immediate result.During index procedure the calcium was carefully removed.The immediate post operative transesophageal echocardiography showed that the valve was correctly implanted without the presence of leaks.As reported, 7 days after procedure, a double mild to moderate paravalvular regurgitation was observed on echo.Another echo performed 10 days later confirmed the two periprosthetic leaks that were unchanged.The patient was discharged home.However, 3 months after implant, the patient was hospitalized for a cardiogenic shock and pericardiac arrest.Reportedly, the valve dislocation had caused a partial rupture of anterior mitral leaflet leading to massive mitral insufficiency.An inspiris resilia valve model 11500a23 was implanted in replacement.At the time of the reported event the patient was noted as to be in the intensive care unit with a good prognosis.However, from new information provided, the patient had a severe multi organ failure in the post operative period with acute hepatitis and renal failure with anuria and the need for dialysis and the patient died 23 days later.Cause of death was multiorgan failure, severe hf / ef at 35 % with severe hypokinesia and hepatorenal failure.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle-2; irvine, CA 92614 ; 9492506615
• MDR Report Key: 8843569
• MDR Text Key: 152759985
• Report Number: 2015691-2019-02822
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• 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; Death
• Patient Age: 53 YR
• Patient Sex: Male