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

Model Number 9600TFX29A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 29mm sapien 3 valve in the aortic position.The case was off-label as aortic insufficiency was the primary failure mode.During the procedure, the physician placed the sheath in the l/r femoral arteries.The valve embolized post deployment and was brought back to the descending aorta without incident.Surgical avr was scheduled for the following day as an outpatient procedure.Patient was stable post procedure.

Manufacturer Narrative

Investigation is ongoing.Remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: clinical code, type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was used in off-label implantation in the aortic position.As there are no specific ifu or training materials related to aortic insufficiency procedures, the available training materials were reviewed only for information potentially relevant to the device use.Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to embolization of the device, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy (in aortic position), minimally or bulky/severely calcified leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and inaccurate measurement of the landing zone, a landing zone with an elliptical shape, and valve under or oversizing.The ifu cautions that incorrect sizing of the valve may lead to paravalvular leak, migration, or embolization.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien thv (all models).Training includes patient screening, device preparation, approach, deployment, imaging, procedurespecific training manuals, and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor in the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for embolization, a balloon valvuloplasty may indicate potential balloon movement during valve deployment.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest that both patient and procedural factors caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16439957
• MDR Text Key: 310192588
• Report Number: 2015691-2023-11086
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250921
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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 Sex: Male