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

Model Number 9600TFX29A

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

Patient Problem Myocardial Infarction (1969)

Event Date 07/01/2021

Event Type  Death  

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 1 myocardial infraction death event for the sapien 3 transcatheter heart valve in the mitral position.The 'time to event' (tte, in days) for this event was 3.00.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve is: (b)(4).Per the instructions for use (ifu), thrombus formation, plaque dislodgement, and embolization of calcific materials that may result in myocardial infarction (mi) are potential adverse events associated with the overall transcatheter mitral valve replacement (tmvr) procedure.The ifu states that caution should be exercised when implanting a bioprosthesis in patients with clinically significant coronary artery disease.Mi related to a transcatheter heart valve (thv) procedure will manifest intra-procedurally or in the immediate post-operative period and is typically due to a combination of patient and/or procedural factors.As defined in the valve academic research consortium (varc) publication on tavr complications, the peri-procedural interval is inclusive of all events that begin within 72 hours of the index procedure.Mi's that occur after the peri-procedural period (>72 hrs.) are typically related to the patient's underlying coronary disease.This applies to tmvr patients, as well as tavr patients.There are multiple patient factors that could put the patient at risk for mi during a thv procedure, including significant underlying coronary artery disease and atherosclerotic deposits along the cardiac anatomy.Displacement of deposits with embolization of debris into one of the arteries can result in this complication.The edwards thv manuals advise the operator on pre-procedure assessment of the cardiac anatomy.Physicians are extensively trained by edwards before they are qualified to use the thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.In this case, specific procedural details are not available to determine potential contributing factors 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

Thv/tvt registry summary reporting for adverse event submission for q3 2021 data extract for mitral deaths for the sapien 3 valve.This report summarizes 1 myocardial infraction event for the sapien 3 valve.The age for this event is (b)(6).The breakdown for gender is as follows: 0 males and 1 female.

Manufacturer Narrative

Correction mdr submitted to provide exemption number in provided field.No new information to report.

Manufacturer Narrative

Resubmitting corrected mdr to provide exemption number in provided field.No new information to report.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 12657164
• MDR Text Key: 277155898
• Report Number: 2015691-2021-05798
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 79 YR
• Patient Sex: Female