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

Model Number 9750TFX26

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.The date of the event is unknown, however, the article was received for publication on the may 1st, 2022.In this case, the received for publication date is used as the occurrence date.Reference article: henryk dreger, md, simon sundermann, md, stefan m.Niehues, md, and ulf landmesser, md.''bail-out implantation of an embolized balloon-expandable transcatheter heart valve in the aortic arch using self-expandable stents''.The american journal of cardiology 2022.

Event Description

As reported from our affiliates in germany, per article, ''bail-out implantation of an embolized balloon-expandable transcatheter heart valve in the aortic arch using self-expandable stents'', an 85 year-old male was referred for the treatment of symptomatic severe aortic stenosis.During valve deployment, loss of capture occurred, resulting in valve embolization into the aortic root.To avoid coronary obstruction, the embolized valve was immediately pulled back into the distal ascending aorta using the semi-inflated delivery balloon.After a successful implantation of a second valve into the aortic annulus, it was decided to positioned the embolized valve between the origins of the brachiocephalic and left carotid arteries.It was decided to secure the embolized valve in the aortic arch by overlapping the implantation of two self-expandable stents.Six months post procedure, the valve was in a stable position with unobstructed blood flow into the supra-aortic arteries.There was no negative outcome.

Manufacturer Narrative

Correction to section h6 codes per evaluation.The valve was not returned to edwards lifesciences for evaluation as it remains implanted in the patient.A review of procedural imagery showed the embolized valve was implanted in the aortic arch.A review of the risk management documentation was performed, and 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 complaint was confirmed based on provided imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.Per the instructions for use (ifu), valve embolization is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic embolization, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and movement of the delivery system by the operator.In this case, it was reported ''during valve deployment, loss of capture occurred, resulting in valve embolization into the aortic root''.Per the training manual, ''loss of capture during rapid pacing can cause sudden delivery system movement during deployment'' and ''make sure pressure stabilizes before balloon inflation.'' in this case, it is likely that the loss of pacing capture disrupted balloon stability during deployment leading to aortic embolization.As such, available information suggests that procedural factors (loss of pacing capture) may have contributed to this complaint event.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative actions nor product risk assessment (pra) escalation are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92883
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16175485
• MDR Text Key: 307472052
• Report Number: 2015691-2023-10214
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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: 06/16/2022
• Device Model Number: 9750TFX26
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male