MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26A

Device Problems Deflation Problem (1149); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problems Cardiopulmonary Arrest (1765); Failure of Implant (1924); Ventricular Fibrillation (2130); Injury (2348)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-12243.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential complication associated with the transcatheter mitral valve replacement (tmvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction (stj), minimally or bulky/severely calcified aortic leaflets, rapid deployment, release of stored tension during 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.In patients with high-risk anatomical features for ventricular malposition (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.In this case, the valve placement too ventricular was most likely due to issues experienced during the inflation and deflation of the delivery system during valve deployment and patient factors (asp and dacron patch).A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.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, this was a planned transseptal case involving the implant of a 26mm sapien 3 valve inside a pre-existing 21mm physio i ring (implanted in 2007).The patient had a complicated medical history with an asp and status post repair with a dacron patch.In addition, the patient had also had another unknown mitral repair in 1999.A 26mm sapien 3 valve and commander delivery system were advanced through the septum.The nosecone of the delivery system was hitting against the icd lead and just as they were able to get the valve through the septum the wire placement was lost, possibly due to the various changes in angle and manipulation to get the device across the septum causing some built up tension.These events are not a result of a malfunction of the devices but were caused by the difficult anatomy and patch making crossing difficult.A second 26mm s3 valve was prepped and while crossing the septum, the nosecone also interacted with the icd lead initially but the physician was able to move past the lead.The valve temporarily became stuck on the septum puncture but after 15 minutes of manipulation was successfully crossed and placed within the mitral ring for deployment.As the surgeon began inflating the balloon for valve deployment a great deal of resistance was noted.It took a lot of effort to deploy the valve but he was able to get it successfully deployed, however he was unable to pull negative and deflate the balloon.The balloon remained inflated for approximately 2-3 minutes, while pacing continued, and the patient went into v.Fib.A 60cc syringe was used to eventually deflate the balloon.The patient needed to be shocked, cpr was performed.Analysis of the deployed valve showed that it was situated much too ventricular.A third 26mm s3 valve was advanced and implanted more atrial, successfully.Of last report the patient was extubated and awake and alert.There was a small amount of pvl noted around the 1st implanted valve noted but no plans to treat that at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10184384
• MDR Text Key: 199086931
• Report Number: 2015691-2020-12244
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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: 12/11/2021
• Device Model Number: 9600TFX26A
• Device Lot Number: 7119501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR