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

Model Number 9600TFX29A

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Failure to Align (2522); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problems Failure of Implant (1924); Tricuspid Regurgitation (2112); No Code Available (3191)

Event Date 06/05/2020

Event Type  Injury  

Event Description

As reported, during a tf thv valve within a tricuspid ring case, three 29mm sapien 3 valves were used.The first valve (sn (b)(4)), implanted with an additional 5cc, was deployed with an "imperfect position".The valve was not seated properly into the surgical ring, and appeared to be canted.A second valve (sn (b)(4)) was implanted within the first with an additional 10cc, but lacked proper leaflet coaptation and exhibited central ai.One of the valve leaflets was noticeably ¿frozen¿ or not moving efficiently.A third valve (sn (b)(4)) was implanted with an additional 6cc, which rectified the leaflet coaptation issue but a plug was still needed for pvl around the first thv and surgical ring.Per the records received, the annuloplasty ring was not well aligned within the native tricuspid valve and the fist valve was therefore implanted more atrial than ideal.The decision was made to flare the ventricular side of the first valve by post-dilating it with +8cc before implanting the second valve more ventricular.After the second valve was placed, one of the leaflets of this new valve appeared to be "malfunctioning and not moving", resulting in moderate to severe transvalvular tricuspid regurgitation.The third valve was placed slightly more ventricular than the second valve with +10cc.There was evidence of paravalvular leak around the transcatheter valves, lateral to it, and the ring.The decision was made to fix the pvl, which was plugged.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2020-12294.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10201010
• MDR Text Key: 199096041
• Report Number: 2015691-2020-12293
• 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: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 9600TFX29A
• Device Lot Number: 7121491
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR