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

Model Number 9600TFX29

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

Patient Problem Infarction, Cerebral (1771)

Event Date 04/26/2019

Event Type  Death  

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2020-12815.  the device identification (di) numbers for edwards sapien 3 transcatheter heart valve is (b)(4).Per the instructions for use, permanent or transient neurological events including stroke are potential adverse events associated with invasive cardiac procedure including transcatheter heart valve procedures.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 less than 30%, diabetes, age older than 70 years, bypass procedure time greater than 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 less than 24 hours 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

Per the information received from the (b)(6) registry for (b)(6) 2020 data extract for mitral deaths for the sapien 3 transcatheter heart valve, a (ischemic stroke) occurred, and the patient expired.No additional information is available for this event.

Manufacturer Narrative

Corrected data: reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10469219
• MDR Text Key: 204859826
• Report Number: 2015691-2020-13370
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• 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
• Patient Age: 82 YR