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

Model Number 9600TFX29

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/25/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.Reference:  leone, alessandro, jacopo alfonsi, emanuele pilato, luigi lovato, luca di marco, giacomo murana, francesco saia, davide pacini, and roberto di bartolomeo."transcatheter mitral valve-in-valve dislocation: a rescue strategy." the annals of thoracic surgery (2018).

Event Description

A case report from an (b)(6)hospital was published in the article ¿transcatheter mitral valve-in-valve dislocation: a rescue strategy¿.According to the authors, the patient has a 31-mm hancock bioprosthesis in mitral position and was recently admitted with heart failure with evidence of mitral bioprosthetic dysfunction.The echocardiography confirmed the severe bioprosthetic mitral regurgitation with elevated pulmonary artery systolic pressure 55 mmhg, moderate aortic valve regurgitation, and a left ventricle (lv) ejection fraction of 61%. the patient was evaluated by the ¿heart team¿ a transcatheter valve procedure was preferred via transapical approach.A left anterior thoracotomy was performed through the fifth intercostal space and transapical access through the pericardial was created.The ventricular apex was punctured with a guidewire, which was advanced through the opening of the mitral prosthesis into the left atrium.Transesophageal echocardiography was not used due to esophageal varices and the coaxial alignment with the ring of the deteriorated bioprosthesis was guided only by fluoroscopy.Before the introduction of the prosthesis the guidewire was accidentally dislocated towards the aortic valve and the 29-mm edwards sapien iii balloon expandable bioprosthesis was wrongly released, through a 21f sheath, in ascending aorta with following migration in aortic arch.The tee was introduced and a new 29- mm sapien iii prosthesis was immediately implanted in the degenerated bioprosthesis using the same approach under fluoroscopy and echocardiography guidance, during rapid ventricular pacing.  fortunately the position of the dislocated mitral prosthesis, perfectly aligned in the arch, did not interfere with the catheters passage.Considering this, the dislocated prosthesis was then successfully stabilized in the aortic arch introducing through the right femoral artery a bare aortic stent, allowing also an adequate perfusion of epiaortic vessels.The patient was extubated 14 hours after the procedure, no complications occurred, the post-operative chest x-ray showed the right positioning of the prosthesis and he was discharged from hospital 8 days after valve implantation with warfarin therapy.The predischarge echocardiogram showed no mitral regurgitation and any paravalvular leakage, mitral valve area was 2.8 cm2 with a mean gradient of 7 mmhg, lv ejection fraction was 43%.

Manufacturer Narrative

It was found during internal review that the complaint events were previously captured and reported under manufacturer report number 2015691-2017-01231.The investigation of the events will remain under the original reports.Therefore, a corrected supplemental report is being submitted.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7660828
• MDR Text Key: 113155709
• Report Number: 2015691-2018-02613
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

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: 9600TFX29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/04/2018
• Supplement Dates FDA Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR