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

Model Number 9600TFX23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Embolus (1830); Extravasation (1842); Paralysis (1997); Dysphasia (2195)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Per the instructions for use, 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, the mechanism described above are likely contributing factors to this event.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

Approximately 3 hours after successful implant of a 23mm sapien 3 valve, the patient had an embolic stroke and right sided facial drooping.A carotid ultrasound was not completed prior to the tavr procedure.Per the hospital records, the patient had an embolic stroke with right hemiplegia and aphasia.Angiography demonstrates a filling defect in the left distal ica just prior to the takeoff of the ophthalmic artery as well as an occluded m2 branch.Attempts to advance a microcatheter in order to retrieve the clot resulted in distal embolization of the distal ica clot into the left m1 which became completely occluded.Attempts at catheter placement resulted in some extravasation and venous filling.The case was therefore terminated.The patient was taken immediately to cat scan for noncontrast head ct for better evaluation.The patient is transferred to the icu in stable condition.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5414277
• MDR Text Key: 37617425
• Report Number: 2015691-2016-00350
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2016

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: 11/18/2016
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/05/2016
• Date Device Manufactured: 12/08/2015
• 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: 75 YR