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

Model Number 9300TFX23J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Heart Failure (2206)

Event Date 11/05/2014

Event Type  Injury  

Event Description

As reported by our japan affiliate, a sapien xt was placed within an existing sapien valve 2 years post tavr.Eight months later, the patient had an exacerbation of chf which was thought to be related to aortic stenosis.A ct performed did not show clearly if there was calcification on the leaflets, but an echocardiogram revealed poor movement of the xt valve cusps.Since the patient¿s condition was deteriorating, bypass surgery and surgical avr were performed.The sapien and sapien xt valves were coalesced with the host tissue, so the operators cut the struts and the valves were explanted.A mechanical valve was implanted.The cusps of the explanted valves were observed to be thickened, hard, and calcified.

Manufacturer Narrative

The explanted valve was returned to edwards lifesciences for evaluation.Investigation of the event is ongoing, pending evaluation of the return device.This report represents the 2nd valve (sapien xt); please reference the related manufacturer report no.2015691-2014-00716 for the report regarding the 1st valve (sapien).

Manufacturer Narrative

A portion of the explanted sapien xt valve was returned to edwards with frame and leaflet separated.Part of the sapien valve was returned as well with patient anatomy/tissue in-growth on the leaflet and frame.During visual inspection it was observed that a portion of the valve was returned in two parts, a portion of the leaflet and two struts of the frame no abnormalities were observed on the returned valve portions.Severe calcification was noted on the piece of returned leaflet.X-ray imaging confirmed tissue calcification of both the detached leaflet remnant and the tissue still attached to the frame.No relevant functional/dimensional analysis was able to be performed because only a small portion of the valve was returned with a separated portion of the leaflet.Segments of the valve leaflets were sent to a laboratory for histology evaluation.Results from the histology evaluation indicated no significant host inflammatory cell infiltration evident in the leaflet tissue.The calcification was confirmed on the tissue for the returned samples, but there was no apparent reason for the calcification revealed by histological examination.Tissue in unaffected areas appears to be reasonably well preserved.According with the histology evaluation report, tissue calcification-mediated structural valvular deterioration (svd) is a chronic and usually late event for the majority of bioprosthetic heart valves.The evaluation concludes that in patients with renal insufficiency or failure, particularly those requiring dialysis, the elevated blood calcium and phosphorous levels, as well as secondary hyper-parathyroidism, are believed to play an important role in the development of the early bioprosthetic heart valve calcification sometimes observed in this subgroup of patients.In this case, the report of prosthetic valve calcification was confirmed on the returned portions of the edwards sapient xt valve, but no manufacturing defects were identified during this investigation.While the histological evaluation was able to confirm the presence of calcium on the returned pieces, it also determined there was no significant host inflammatory cell infiltration present in the leaflet tissue.In this case, it appears that the events were related to the natural progression of the patient¿s pre-existing conditions.Patient information provided indicates that the patient was on dialysis treatment, which is the most likely root cause of the valve¿s premature calcification and eventual degradation in performance (described as ¿poor movement¿ per the report).In addition, per the (b)(6) ifu, chronic dialysis patients are excluded from the intended use of the sapien xt valve.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.

• Brand Name: EDWARDS SAPIEN XT 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: 4277385
• MDR Text Key: 5296987
• Report Number: 2015691-2014-02802
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2014

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: 06/14/2015
• Device Model Number: 9300TFX23J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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