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

Model Number 9600TFX23J

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Regurgitation (1964)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The valve was not returned to edwards lifesciences for evaluation, as it remains implanted in the patient.The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator).Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, a severely elliptical annulus shape, valve under-sizing.Per the instructions for use (ifu), conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, deployment of the prosthetic valve, and the overall tavr procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may provide an explanation for these complications of the tavr procedure.According to literature review, and as documented in a technical summary written by edwards lifesciences ¿clinical technical summary for complaints-conduction disturbances/ heart block¿, atrioventricular conduction disturbances after tavr are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, tavr may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after tavr are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing tavr or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, after the 23mm sapien 3 valve was implanted via transfemoral tavr procedure, worsening mitral regurgitation (mr) was observed and the patient became hemodynamically unstable.The patient was stabilized and later recovered. additionally, a permanent pacemaker was implanted post tavr, (exact date unknown).As reported, the valve was oversized +1cc which may have impacted the mr.There was no allegation or indication a device malfunction contributed to this adverse event.The device was not returned for evaluation, as it remained implanted.The root cause of this event remains indeterminable but was likely due to patient related factors and/or procedure related factors.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 at this time.

Event Description

After the 23mm sapien 3 valve was implanted via transfemoral tavr procedure, hemodynamic instability due to worsened mitral regurgitation (mr) occurred.The valve was implanted with 1ml more than nominal volume.After the implantation, blood transfusion and fluid replacement were required to stabilize the blood pressure and hemodynamics.The tee revealed worsened mr and it was concluded that the mr was the likely cause of hemodynamic instability.The iabp was inserted and patient was intubated.  the calcification of the aortic valve was moderate to severe.It was reported that there was a discrepancy in the annulus area measurement figures and the ct was not clear, therefore exact measurement was difficult.As a result, the valve was oversized which may have impacted the worsening mr.The patient was stabilized with iabp after the procedure.The iabp was later discontinued and the patient was extubated.A permanent pacemaker was implanted post tavr, however exact date is unknown.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY
• 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: rene dorne ; 1 edwards way; linc 4-1; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10555563
• MDR Text Key: 207709311
• Report Number: 2015691-2020-13630
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2022
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2020
• Date Device Manufactured: 05/04/2020
• 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
• Patient Age: 81 YR
• Patient Weight: 60