MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23A

Device Problems Fracture (1260); Gradient Increase (1270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The investigation is ongoing.

Event Description

Approximately 3 year and 4 months post implant of a 23mm sapien 3 valve within a failed non-edwards surgical valve in the aortic position, the patient developed increased gradients of 61mmhg.The valves were fractured with a 22 balloon and a second 23mm sapien 3 valve was implanted.The valves were post dilated with a 23 balloon.The gradient was reduced to 15mmhg on echo.The patient left the or in stable condition.

Manufacturer Narrative

The patient¿s medical records were received.Sections a2, a3 and b7 were updated.Per the medical records, approximately 1 year post procedure, prosthesis mismatch was observed.The valve was adequately opening.Tee showed a mean gradient of 27mmhg and vmax 370 cm/s.Approximately 2 year post procedure, echo showed an ef (b)(4) , peak gradient 65 mmhg, mean 36mmh, and ava 0.96cm2.Edwards s3 tavr valve in valve appears well seated without evidence of central or paravalvular leak.Approximately 2.5 year post procedure, echo showed ava 0.94 cm2, peak gradient 82 mmhg, and mean 47 mmhg.Approximately 3 year post procedure, echo showed an ef(b)(4) , severe concentric septal hypertrophy, ava 0.8cm2, peak gradient 68mmhg, and mean gradient 35mmhg.Approximately 3 year and 4 months post procedure, the patient had severe as and patent patient prosthesis mismatch evaluated.The valves were fractured and a second 23mm sapien 3 valve was implanted.Post implant gradients were still elevated at 20mmhg and post dilation was performed with a 23mm bav.The implant was a success with no evidence of paravalvular of central regurgitation and residual mean gradient of 12-15mmhg.The patient was discharged home on post-operative day 2.Approximately 1 month post procedure, tte showed a 23mm sapien 3 valve in valve with an av gradient 66mmhg, mean gradient 31mmhg, ava 0.73 cm2, trace pvl, and av peak velocity 406 cm/s.It is normal to have a small gradient across a prosthetic valve after implant.If elevated, it may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular aortic stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to calcification or early thrombus formation.In the instance of a bioprosthetic valve in valve implant an increased gradient can be a result of intravalvular regurgitation and is not a result of a valve leaflet malfunction.If mild, these patients will not require intervention and will be followed with serial echocardiography.If significant and results in symptoms, it may require intervention.Per the valve academic research consortium (varc), prosthetic heart valve device success is described as no prosthesis-patient mismatch and mean aortic valve gradient <20 mmhg or peak velocity <3 m/s, and no moderate or severe prosthetic valve regurgitation.Valve-related dysfunction (structural valve deterioration) is described as a mean aortic valve gradient >20 mmhg, eoa <0.9¿1.1 cm2 and/or dvi <0.35 m/s, and/ or moderate or severe prosthetic valve regurgitation requiring repeat procedure (tavi or savr).In the short term, abnormally high gradients may indicate a leaflet that is not functioning optimally, while in the longer term an abnormally high gradient could result from calcification of the leaflets.Abnormally low gradients may be a symptom of regurgitation.Patient prosthesis mismatch (ppm) has typically referred to a situation in which the effective valve area after surgical valve replacement is less than that of a normal human valve.In the aortic position, severe ppm is defined by an indexed effective orifice area of <0.65 cm2/m2, and the incidence of severe ppm after surgical aortic valve replacement ranges between(b)(4) and(b)(4).According to literature review, it has been suggested that predictors of ppm after surgical aortic valve replacement include older age, female sex, hypertension, diabetes mellitus, renal failure, larger body surface area, larger body mass index, and the utilization of a bioprosthesis.Furthermore, the presence of ppm is prognostically important because ppm results in higher valve gradients and increased perioperative and overall mortality.In this case, the device is not available for evaluation as it remains implanted in the patient.However, there was no allegation or indication a device malfunction contributed to this adverse event.As reported, the increase in gradient across the valve was likely due to patient prosthesis mismatch secondary to the valve in valve.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10290508
• MDR Text Key: 200654632
• Report Number: 2015691-2020-12559
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2020

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 Expiration Date: 10/24/2017
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 08/03/2020; 07/23/2020
• Supplement Dates FDA Received: 08/24/2020; 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR