MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TF NF3 DEL SYS, 29MM, COM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9355FS29

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is one of two manufacturer reports being submitted for this case.The report represents the first valve used.Difficulty tracking the delivery system (ds) through the vasculature may be due to anatomical and/or procedural factors, including tortuous vessels, previously implanted stents and/or grafts, wire bias, and kinked ds.In most instances this resolves with routine troubleshooting maneuvers, with minimal risk to the patient.In severe cases, if the delivery system cannot track to the native annulus, the valve may be deployed in a non-target location, or retracted and removed through a surgical cutdown.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.There may be cases in which the valve is not able to be deployed at the intended location.This may require deploying the valve at a non-target location.Although, generally well tolerated, the long term effects are not completely understood.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate the patient¿s anatomy contributed to the tracking difficulty and resulting valve placement at a non-target location.Device deployment in unintended location is listed in the ifu.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

As reported by our affiliates in (b)(4), during implant of a 29mm sapien xt valve in the pulmonic position via transvenous approach, there was difficulty crossing the pulmonic valve due to a malformations/hardness in the patient anatomy after several previous interventions.After several maneuvers with pods of different types, including the use of a loop to try to position the valve correctly, the attempt was aborted.The valve was implanted in the mouth of the inferior vena cava.Access was then attempted with a second valve via the jugular vein.The access route had a smaller distance, but was more complex.The patient began to decompensate and had an abrupt decrease in blood pressure, therefore, the procedure was aborted.The valve was implanted at the mouth of the superior vena cava.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2018-00798.

• Brand Name: TF NF3 DEL SYS, 29MM, COM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 7322379
• MDR Text Key: 101833540
• Report Number: 2015691-2018-00797
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2018
• Device Model Number: 9355FS29
• Device Lot Number: 60339531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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): Required Intervention
• Patient Age: 39 YR