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 Problem Heart Block (4444)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 1 permanent pacemaker serious injury events for the sapien 3 transcatheter heart valve in the mitral position.The 'time to event' (tte, in days) for this event was 7.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.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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 q1 2022 data extract for mitral serious injuries for the sapien 3 valve.This report summarizes 1 permanent pacemaker event for the sapien 3 valve.The age for this event is (b)(6).The breakdown for gender is as follows: 1 female.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14120350
• MDR Text Key: 289355652
• Report Number: 2015691-2022-05173
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: 2016006
• 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
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• 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: 76 YR
• Patient Sex: Female