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

Model Number 9600TFX

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

Patient Problems Myocardial Infarction (1969); Insufficient Information (4580)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 1 event of myocardial infarction for the sapien 3 valve in the mitral position.The ¿time to event¿ (tte, in days) for this event was 3.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(4).Per the instructions for use (ifu), thrombus formation, plaque dislodgement, and embolization that may result in myocardial infarction (mi) are potential adverse events associated with the overall tavr procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets in close proximity to the coronary ostia.In addition, caution should be exercised when implanting a bioprosthesis in patients with clinically significant coronary artery disease.Mi related to the tavr procedure and the valve implant 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 hrs of the index procedure.Mi¿s that occur after the peri-procedural period (>72hrs) are typically related to the patient¿s underlying coronary disease.There are multiple patient factors that could put the patient at risk for mi during the tavr procedure, including significant underlying coronary artery disease, and bulky calcification of the native leaflets and root.  displacement of calcium deposits with embolization of debris into one of the arteries, or aortic dissection with continuity of the rupture into the intima of one of the coronary ostia, can result in this complication.The edwards thv manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (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 august 2020 data extract for mitral serious injury events for the sapien 3 valve.This report summarizes 1 event of myocardial infarction for a (b)(6) year old female patient in the mitral position.August 2020 data extract includes data provided by acc for 2020 q1 (january 1 ¿ march 31, 2020).

Manufacturer Narrative

Supplemental report to add noe statement in b5 section, and provide d5, and h6 information.

Event Description

This report summarizes 1 event of myocardial infarction serious injury event for the sapien 3 in the mitral position for (b)(6) 2020.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10881873
• MDR Text Key: 217997862
• Report Number: 2015691-2020-14607
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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 Model Number: 9600TFX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/22/2020
• Supplement Dates Manufacturer Received: 11/22/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR