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

Model Number 9000TFX23

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Thrombosis (2100)

Event Date 04/21/2014

Event Type  Injury  

Manufacturer Narrative

Echo images were provided to edwards for review.The images were reviewed by an edwards physician, and the following observations and impressions were provided: observations: transthoracic echo (tte) 6 days post implant demonstrates a sapien valve with its ventricular aspect at the level of a ventricular septal bulge.There is evidence of severe transvalvular ar and a membranous vsd extending into the rv.The location of the non-functioning leaflet coincides with either the right coronary cusp (rcc) or the non-coronary cusp (ncc).The presence of native leaflet overhang is questionable on this tte.There is a possibility of thrombus extending above the aortic aspect of the valve.The sapien lcc appears to be moving normally.Impressions: there is severe transvalvular ar secondary to a non-functioning leaflet of uncertain etiology.There is also a membranous vsd.The timing of the ar and vsd cannot be ascertained from this single echo performed 6 days post tavr.During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect would contribute to the event.In this case, the cause of the non-functioning leaflet could not be determined from the provided echo image.However, per report, there appeared to be native leaflet overhang restricting the prosthetic valve leaflet motion.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

On routine tte 5 days post sapien valve implant, severe ai was noted.The patient was taken back to the or on pod6 and underwent a valve in valve procedure.Initially a 23mm valve implanted via transfemoral approach and final tee result was trace pvl.There was laa clot found on procedural tee, however, it was decided to continue with the planned procedure.Due to a post procedural groin hematoma, the patient went off anticoagulation.Tte 5 days post tavr procedure severe central regurgitation, with right coronary leaflet dysfunction was noted on tte.Patient without significant symptoms.The patient was brought back to the or, tee confirmed the right coronary leaflet was non-functioning and it looked as if the left coronary leaflet was now involved.By tee and angio it did not appear the valve had migrated, but rather there were native leaflets overhanging causing the severe central regurgitation.Due to the groin hematoma and concern of dislodging the initial valve when crossing, it was decided to do a ta approach and place a second 23mm sapien valve.The second valve was prepared and positioned slightly higher.There was a miscommunication amongst the team and the valve was inflated prior to confirming adequate pressure drop with rapid pacing and before the entire team was ready.There was movement caudally then cranially and the final position was 1 cell higher than the original valve; this caused some flaring on the outflow of the valve and a moderate central regurgitation was present.After much evaluation the team decided not to place a third valve and the moderate central regurgitation was left, apex was closed and the patient transferred to the unit.

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

• Brand Name: SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC 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: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3816058
• MDR Text Key: 12046591
• Report Number: 2015691-2014-01169
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2014

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 Expiration Date: 01/08/2015
• Device Model Number: 9000TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 05/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2013
• 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