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

Model Number 9750TFX23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), permanent or transient neurological events such as transient ischemic attack (tia) and stroke are known potential adverse events associated with the transcatheter heart valve (thv) procedure and the use of the edwards thv devices.According to the literature review, and as documented in a technical summary written by edwards lifesciences, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing thv.Risk factors correlating with several patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during thv are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during thv 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 thv and avr patients.After thv, there appears to be a more significant proportion of early strokes occurring < 24 h post-procedure, but thv patients with multiple co-morbidities are probably at higher risk of both early and late strokes.Per the instructions for use (ifu), stroke is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate patient factors (age, previous history of stroke, and diabetes mellitus) may have caused or contributed to this event.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 this adverse event is not required at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Device remains implanted.

Event Description

As reported from our affiliates in spain, approximately nine days post transfemoral transcatheter aortic valve replacement (tavr) procedure with a 23mm sapien 3 ultra valve, an 86 year old patient was admitted to the emergency room due to weakness of the lower limbs and inability to stand up.It was noted that the patient had been discharged post tavr procedure and was hemodynamically stable and asymptomatic.The patient was only given antiplatelet therapy with aspirin.After the patient was admitted, the patient was examined and was observed with moderate left supranuclear facial paresis, mild left hemiparesis and dysmetria in the left upper limb and left lower limb.The stroke had a lacunar profile.Mechanical thrombectomy was ruled out as a cause for the stroke.The patient was then admitted to the stroke unit for monitoring and a decision was made to start the patient on double antiplatelet therapy with a load of clopidogrel.During the patient's stay in the stroke unit, the patient was hemodynamically stable with no new neurological issues.The patient was then discharged and began walking rehabilitation with preserved mobility in the lower limbs.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15951333
• MDR Text Key: 305179277
• Report Number: 2015691-2022-09782
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: 9750TFX23
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 64 KG