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

Model Number 9600TFX26A

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

Patient Problems Arrhythmia (1721); Complete Heart Block (2627)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 1 event of conduction/native pacer disturbance requiring pacer for the sapien 3 valve in the mitral position.The ¿time to event¿ (tte, in days) for this event was 1.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

Thv/tvt registry summary reporting for adverse event submission for (b)(6) 2020 data extract for mitral serious injuries for the sapien 3 valve.This report summarizes 1 event conduction/native pacer disturbance requiring pacer serious injury event for the sapien 3 transcatheter heart valve in the mitral position for (b)(6) 2020.The age range for these events is from 66.The breakdown for gender is as follows: 1 male.(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 and provide information.

Event Description

This report summarize 1 event of conduction/native pacer disturbance req pacer serious injury events for the sapien 3 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, a conduction/native pacer disturbance requiring pacer serious injury event occurred.No additional information is available for this event.

• 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 (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: 10342212
• MDR Text Key: 202349560
• Report Number: 2015691-2020-12793
• 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: 07/27/2020

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: 9600TFX26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 07/29/2020; 08/25/2020
• Supplement Dates FDA Received: 07/30/2020; 08/26/2020
• 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): Other
• Patient Age: 66 YR