MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 ULTRA; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX23

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

Patient Problems Infarction, Cerebral (1771); Transient Ischemic Attack (2109); Injury (2348)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 1 event of ischemic stroke for the sapien 3 ultra valve in the mitral position.The ¿time to event¿ (tte, in days) for this event was 8.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: (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 thv devices.According to literature review, and as documented in a clinical technical summary 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 event may be related to the mechanism described above.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

Thv/tvt registry summary reporting for adverse event submission for (b)(6) 2020 data extract for mitral serious injuries for the sapien 3 ultra valve.This report summarizes 1 event of ischemic stroke serious injury event for the sapien 3 ultra transcatheter heart valve for (b)(6) 2020.The age range for this event is 56.The breakdown for gender is as follows: 1 female.(b)(6) 2020 data extract includes data provided by acc for q4 2019 (october 1 ¿ december 31).

Manufacturer Narrative

Supplemental report to add noe statement in event description field, and provide device information and problem codes information.

Event Description

This report summarize 1 events of ischemic stroke serious injury events for the sapien 3 ultra for (b)(6) 2020.

Manufacturer Narrative

This report have been updated.Additionally, at the time the initial report for this mitral event was submitted, the event did not meet the tvtr criteria for summary reporting under exemption e2016006.

Event Description

Per the information received from the thv/tvt registry for (b)(6) 2020 data extract for mitral serious injuries for the sapien 3 transcatheter heart valve, an ischemic stroke occurred.No additional information is available for this event.

• Brand Name: EDWARDS SAPIEN 3 ULTRA
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10335650
• MDR Text Key: 202182480
• Report Number: 2015691-2020-12769
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• 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): Other
• Patient Age: 56 YR