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

Model Number 9600TFX29

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); Difficult or Delayed Activation (2577); Positioning Problem (3009); Migration (4003)

Patient Problems Calcium Deposits/Calcification (1758); Complete Heart Block (2627)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.Reference for article: krapf, s., von scheidt, w.& thilo, periprocedural embolisation of a sapien 3 tavi prosthesis: failure and success (2019).C.Clin res cardiol (2019).Https://doi.Org/10.1007/s00392-019-01573-0.Https://link.Springer.Com/article/10.1007/s00392-019-01573-0.

Event Description

As reported by our affiliate in (b)(6) and through an article, ¿periprocedural embolization of a sapien 3 tavi prosthesis: failure and success¿ a 29mm sapien 3 valve was implanted via the transfemoral approach.As the sapien 3 prosthesis was advanced towards the abdominal aorta, adjusting the dilatation balloon into the valve was hampered due to heavy tortuosity of the abdominal aorta.After advancing to implantation level and pusher retraction, a 2 mm very deep distal balloon marker was recognized, but accepted.Subsequently, the prosthesis was released under rapid pacing.Due to slipping of the balloon towards the ventricle while inflating, the prosthesis opened in a trapezoid shape.During the same period of rapid pacing, the balloon was retracted and reinflated.The prosthesis now opened adequately but was in a very low position.Angiography after a couple of seconds revealed the valve migrated into the lvot.The patient was intubated and transferred to the hybrid or with the extra stiff wire stabilizing the dislocated prosthesis still in place.After gaining access, the prosthesis was grabbed with two pairs of anatomical tweezers and pulled back in the intended position.A 29mm transapical (ta) delivery system was prepared and balloon dilatation with an additional 3 ml volume was performed.Subsequent transthoracic echocardiography confirmed excellent position and function of the prosthesis.The hospital stay was prolonged by pacemaker (pm) implantation on day 6 after tavi for third-degree av blockage and an inferior pericardiotomy on day 1 after pm due to rv penetration.The patient was discharged home in unremarkable cardiovascular and neurologic condition.The native annular diameter measured 26.9mm with an ava of 0.9cm2.Moderate valvular calcification and ¿heavy¿ tortuosity of the abdominal aorta were reported.

Manufacturer Narrative

Additional information: section h10.Edwards lifesciences has investigated the reported event.It has been confirmed that this event was previously reported under manufacturer report 2015691-2017-03717.On this basis, it has been determined that this event does not meet the criteria of a complaint or a reportable event.

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: 9560369
• MDR Text Key: 175014761
• Report Number: 2015691-2020-10068
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• 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: 83 YR