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

Model Number 9600TFX23A

Device Problems Fracture (1260); Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Reference article: aoki, yasuhiro, adam arnofsky, ramin s.Hastings, and joseph de gregorio."protecting stent trapped between surgical and transcatheter aortic valve in valve-in-valve procedure." cardiovascular intervention and therapeutics (2019): 1-2.  investigation is underway.

Event Description

As reported through article "protecting stent trapped between surgical and transcatheter aortic valve in valve-in-valve procedure" the following event was reported: the procedure was performed via transfemoral.A stent was left undeployed in the lad.After deployment of the sapien 3 valve (s3), there was a residual mean gradient of 37 mmhg.The bioprosthetic valve was then fractured with a non-edwards device, which reduced the gradient to 8 mmhg.As the coronary flow was not limited, the coronary stent system was removed.Upon removal, the stent was noted to no longer be attached to the delivery system and was seen angiographically trapped against the s3. snaring the stent was unsuccessful.The ivus demonstrated that the stent was fully out of the left main and the proximal stent edge was pinched between the s3 and the stent post of the bioprosthetic valve.As the stent was well fixed at the position, no further attempts were made.The patient was discharged at day four.We planned 6 months of dual antiplatelet therapy (our routine is 3 months) and 60-day follow-up was uneventful.

Manufacturer Narrative

The device was not returned for evaluation; however, there was no allegation or indication of an edwards device malfunction.  review of imagery provided by the article shows left coronary height at 5.1mm.  per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tavr procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia.The edwards thv training manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.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 physician is instructed to evaluate this risk early in the patient screening process in all patients the following factors should be considered: degree of calcification on leaflets, annulus to coronary ostia distance, length of the valve leaflet, width of the valsalva sinuses, movement of the leaflets during bav, patency of coronaries during bav, and expanded height of the intended thv.  in this case, the event appears to be related to patient factors (minimal distance between the native annulus and the coronary ostia; 5.1mm and narrow stj; 27.7cm) and procedural factors (device manipulation).  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.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8448629
• MDR Text Key: 139749842
• Report Number: 2015691-2019-01016
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2019

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 Model Number: 9600TFX23A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 04/01/2019; 07/23/2020
• Supplement Dates FDA Received: 04/02/2019; 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR