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

Model Number 9600TFX23A

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Thrombus (2101)

Event Date 08/09/2020

Event Type  Death  

Manufacturer Narrative

Udi: (b)(4).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.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.In this case, there was no allegation or indication a product deficiency contributed to this adverse event.With the limited information provided, the cause of the increased gradient, suspected thrombus, and worsening pvl is unknown; however, patient factors, such as the patient¿s advanced age and code status dnr/dni may have contributed to the events.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.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.

Event Description

As reported, approximately 1 year, 9 months post successful tavr the patient was admitted for pneumonia, however an echo showed a mean gradient of 35mmhg and a vmax of 3.8m/s.The leaflets appeared thickened and/or abnormal coaptation.There was moderate pvl around the valve.Peak gradient was 63mmhg, valve area 0.52cm2.The patient passed away but the cause of death was unclear.Additional information via medical records stated the patient was admitted for abdominal pain and hypotension, ongoing for about 4 weeks.Workup revealed possible sepsis due to pneumonia with elevated wbc's.Ct was negative for pe or any obvious cause of abdominal pain.Tte during her hospitalization revealed the aortic prosthesis was noted to be in place with moderate pvl and findings consistent with severe degeneration vs.Leaflet thrombosis.The aortic mean gradient was 34.9mmhg.Moderate-to-severe tricuspid regurgitation with pulmonary hypertension were also noted.The patient was dnr/dni.The patient became hypotensive and went into a-fib with rvr.Iv amiodarone was restarted and the patient was treated with iv hydrocortisone and antibiotics, but despite these efforts the patient did not improve and expired.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10483513
• MDR Text Key: 205324046
• Report Number: 2015691-2020-13408
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2020
• Device Model Number: 9600TFX23A
• Device Lot Number: 5835771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2020
• Date Device Manufactured: 02/13/2018
• 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): Death
• Patient Age: 91 YR