MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES VALVE UNKNOWN; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EDWARDS LIFESCIENCES VALVE UNKNOWN

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Operating System Becomes Nonfunctional (2996)

Patient Problems Stroke/CVA (1770); Hemorrhage, Cerebral (1889)

Event Type  Injury  

Manufacturer Narrative

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 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 this adverse event.  attempts were made to obtain patient details but no information has been obtained.Based on the limited information provided, the cause of the stroke is unknown; however, it is possible the mechanisms of the tavr procedure described above or patient factors not provided may have caused or contributed to the 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

As reported by an edwards lifesciences affiliate in (b)(6), per the written article, "self-expandable tavi is associated with frequent hot-spot on magnetic resonance imaging", 47 cases of asymptomatic stroke were reported.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS LIFESCIENCES VALVE UNKNOWN
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8454440
• MDR Text Key: 139956018
• Report Number: 2015691-2019-01045
• Device Sequence Number: 0
• Product Code: NPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EDWARDS LIFESCIENCES VALVE UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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): Other