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

Model Number 9000TFX23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 04/02/2014

Event Type  Injury  

Event Description

Per report, upon placement of a temporary pacing wire for tavr, the patient went into a rapid af and became hypotensive.The patient was cardioverted prior to pacer testing and finding the co-planar view.Upon sheath insertion into the lv, the patient again became hypotensive but maintained a pressure of 90mmhg systolic.Post bav the patient was slow to recover and systolic pressure was 50mmhg.The 23mm sapien was introduced, positioned and deployed utilizing held respirations and rvp.Post deployment the patient had no blood pressure and it was noted via tee that the lv and rv were minimally contracting.1cc of epinephrine was administered via the ascendra sheath with 30 seconds of chest compressions.The patient's pressure recovered.Tee noted equalization of aortic and lv diastolic pressure and what appeared to be a non-functioning anterior leaflet.This was also noted on the hemodynamic waveform.Iabp was initiated.A 2nd 23mm sapien was deployed slightly more aortic (less than a full cell).Epinephrine was again administered with 10 seconds of chest compressions.The patient¿s pressure recovered and tee showed no central ai and trace pvl.The iabp was set to 1:4 augmentation.The sheath was removed and the site closed in the usual surgical fashion.The patient was discharged to a rehabilitation facility 2 weeks later.

Manufacturer Narrative

This report represents the 1st sapien valve implanted.Investigation of this event is ongoing.

Manufacturer Narrative

There are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or non-functioning leaflet.Based on historical review of complaints, these events are typically a result of too ventricular deployment of the valve in combination with native leaflet overhang.Other potential contributing factors include: leaflet impingement in a highly calcified native valve, impingement of a leaflet due to the guide wire, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.This can result in a temporary decrease in the pressure gradient between the ventricle and the aorta, resulting in an inadequate pressure change to close the leaflets.In many instances this can be overcome with trouble shooting, which includes blood pressure recovery or support.Occasionally there are cases where the root cause of the non-functioning leaflet cannot be determined.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 or device malfunction would contribute to the event.Imaging review of the reported event could not be performed, as only tee images prior to the sapien valve deployment were provided.Observations (tee from (b)(6) 2014 10:30am): on tee mid-esophageal long axis view, there is severe bulky calcification of the non coronary cusp (ncc) and left coronary cusp (lcc) and a relatively immobile, severely calcified right coronary cusp (rcc) was observed.Anterior leaflet of the mitral valve demonstrates normal mobility.The aortic root is calcified, but otherwise appears normal.Mid esophageal short axis view confirms bulky calcification ncc> lcc.Impressions: although there is evidence of possibly a guide wire extending through the native aortic valve, there are no views of the delivery system and sapien valve.Furthermore, there are no images of a deployed sapien valve allowing further investigation of the non-functioning leaflet.No cine images from the tavr procedure were available for review.In this case, the cause of the reported non-functioning anterior leaflet cannot be confirmed; however, the patient recovered slowly after the pacing runs performed prior to valve deployment, which appears to be associated to the patient¿s advanced age ((b)(6) years) and cardiac comorbidities (e.G.Bi-ventricular failure with ef=35%, cad s/p cabgx3).It is possible that the lack of an adequate ventricular flow post valve deployment and the severely calcified native valve rcc may have contributed to the event.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.This is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2014-00969.

• Brand Name: EDWARDS 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: 3776299
• MDR Text Key: 4436196
• Report Number: 2015691-2014-00968
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 9000TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2013
• 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
• Patient Age: 82 YR
• Patient Weight: 84