MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM); PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9300TFX26

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.The edwards sapien xt transcatheter heart valve is indicated for use in pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (rvot) conduit with a clinical indication for intervention and pulmonary regurgitation >= moderate and/or mean rvot gradient >= 35 mmhg.Per the instructions for use (ifu), valve migration requiring intervention is a potential adverse event associated with transcatheter pulmonic valve replacement.Less-than-severe and non-uniformly distributed calcification, incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.The edwards thv patient screening manual advises the operator on pre-procedure assessment of the pulmonary vasculature, taking into consideration the degree and distribution calcification.The procedural didactic instructs 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 transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct sizing, alignment and positioning of the device are emphasized as key factors to the placement and fixation of the device.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate the valve migration was due to poor alignment of the sapien xt valve during positioning.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 26mm sapien xt valve within a pre-existing 27 mosaic surgical valve in the pulmonic position, the valve embolized into the distal right pulmonary artery (rpa).The sapien xt valve was lodged in the distal rpa.The procedure was stopped and the patient was referred to surgery.At the time of the report, the patient was stable.The valve embolization was perceived to be due to poor alignment of the sapien xt valve during positioning.

Manufacturer Narrative

Additional information was received.The poor alignment was due the radiopaque markers of the bioprosthetic valve not being lined up properly on the fluoroscopy image during valve deployment.Therefore, when the sapien xt valve expanded, it missed the sewing ring and embolized.The information does not change the results of the investigation.

Manufacturer Narrative

Additional information was received.The sapien xt valve was removed from the right pulmonary artery and a new surgical valve implanted.At last report, the patient was doing well and was discharged home.Additional information was not available.Additionally, corrections to sections f10 and h10 are being submitted.The device is not available for evaluation as it remains implanted in the patient.The edwards sapien xt transcatheter heart valve is indicated for use in pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (rvot) conduit with a clinical indication for intervention and pulmonary regurgitation >= moderate and/or mean rvot gradient >= 35 mmhg.Per the instructions for use (ifu), device embolization is a known potential complication associated with the transcatheter pulmonary valve replacement procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, loss of pacing capture, rapid deployment and movement of the delivery system by the operator.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.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.There was no allegation or indication a product deficiency contributed to this adverse event.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate the valve embolization was due to poor alignment of the sapien xt valve during positioning.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.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM)
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7507709
• MDR Text Key: 108023258
• Report Number: 2015691-2018-01809
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention