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

Model Number 9600TFX

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

Patient Problem Arrhythmia (1721)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 3 events of conduction/native pacer disturbance req pacer the sapien 3 ultra transcatheter heart valve in the mitral position.The ¿time to event¿ (tte, in days) for this event was 14.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(4).Per the instructions for use, conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with invasive cardiac interventions, including the use of transcatheter heart valves.Conduction system disturbances during tmvr may be related to several patient factors (pre-operative co-morbid status, the degree mitral annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities) and procedural factors (depth and profile of the implanted prosthesis, sheath, wire and delivery system manipulation).In this case, specific patient and procedural factors are not available; however, the conduction disturbance may be related to the potential contributing factors 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 at this time.

Event Description

This report summarize 3 events of conduction/native pacer disturbance req pacer serious injury events for the sapien 3 transcatheter heart valve in the mitral position for august 2020.The age range for these events is from 60 to 73.The breakdown for gender is as follows: 2 males and 1 females.August 2020 data extract includes data provided by acc for q1 (january 1 and march 31).

Event Description

This report summarize 3 events of conduction/native pacer disturbance req pacer serious injury events for the sapien 3 transcatheter heart valve in the mitral position for (b)(6) 2020.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10886778
• MDR Text Key: 218679503
• Report Number: 2015691-2020-14622
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 3
• 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

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Other