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

Model Number 9600TFX23J

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Death (1802); Complete Heart Block (2627)

Event Date 12/20/2018

Event Type  Death  

Manufacturer Narrative

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 clinical technical summary written by edwards lifesciences, 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.Per the instructions for use (ifu), permanent or transient neurological events including stroke are potential adverse events associated with the tavr procedure and the use of the edwards thv devices.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing tavr.Risk factors correlating with a number of patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during tavr are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during tavr demonstrated that the majority of procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post-procedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no important differences in the frequency of late strokes between tavr and avr patients.After tavr, there appears to be a more significant proportion of early strokes occurring < 24 h post-procedure, but tavr patients with multiple co morbidities are probably at higher risk of both early and late strokes.In this case, there was no allegation or indication a device malfunction contributed to the reported adverse events (complete av block and cerebral infarction).Investigation results suggest/indicate in addition to procedural factors (pressure from the implanted valve on cardiac structures), patient factors (severe valvular calcification, severe aortic root calcification, severe mac) likely contributed to the complete av block observed post valve deployment.Investigation results suggest/indicate in addition to the procedure itself, patient factors (female gender, advanced age, severe valvular calcification, severe aortic root calcification) likely contributed to the cerebral infarction and subsequence death on pod11.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.

Event Description

As reported by our affiliate in (b)(6) and through the japanese tavi case registry, during a transfemoral tavr procedure, a 23mm sapien 3 valve was deployed in a final 80:20 aortic/ventricular (a/v) position as intended.Post valve deployment, complete atrioventricular (av) block occurred.The patient was transferred with the temporary pacer in place.No further actions were reported for the complete av block.It was also reported that during the tavr procedure, a ¿disturbance of consciousness¿ was observed.Ct indicated a ¿wide range¿ of cerebral infarction.Post procedure, the patient¿s general condition gradually deteriorated and the patient eventually passed away on postoperative day (pod) 11.The valve remains implanted in the patient.The native annular diameter measured 21.0mm.Severe valvular calcification and severe aortic root calcification was reported.Per medical opinion, the relationship of the cerebral infarction to the implanted valve was denied; however, the cerebral infarction was related to the tavr procedure.Per the physician, the cerebral infarction may have developed during the procedure.

Manufacturer Narrative

Corrected data: reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8275228
• MDR Text Key: 134035954
• Report Number: 2015691-2019-00256
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2020
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 91 YR
• Patient Weight: 42