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

Model Number 9600TFX29

Device Problem Material Deformation (2976)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : pending device return.

Event Description

As reported by our edwards lifesciences affiliate in sweden, during the transfemoral transcatheter aortic valve replacement (tavr) procedure with a 29 mm sapien 3 valve, during valve alignment, one of the valve struts on the skirt side was noticed to be pointing outward.The delivery system balloon had not been inflated.A decision was made to withdraw the system, but the system was unable to be withdraw through the esheath.The valve strut was stuck against the vessel wall in the groin area, approximately 1.5 cm from the access site.The system was surgically removed.It was noted that additional pull force had been applied during the removal of the system.There was an injury to the vessel which was repaired.The procedure then proceeded with a second implant attempt using a new system.The other femoral vessel was used for the second implant attempt and the second valve used was implanted successfully.

Manufacturer Narrative

A supplemental mdr is being submitted to include additional information provided.The following section of this report has been updated: h10 (provide narrative/data).Additional information was received revealing the first delivery system and valve had been removed via an open surgery.The injury noted to the vessel was repaired and treated with a patch.The investigation is still ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on further investigation.The following sections of this report have been corrected/updated: h6 (type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was returned to edwards lifesciences for evaluation.Imagery was also provided for evaluation.Review of the provided imagery revealed one (1) bent strut outwards, approximately 30 degrees, at the inflow side prior to valve alignment.It was also noted that the valve struts at the outflow side appeared to have interacted with the sheath tip during withdrawal of the system.It was noted that there was presence of tortuosity in the patient's access vessels as well as calcification in the abdominal aorta, just past the bifurcation.The returned device was visually inspected and one (1) strut was observed to be bent outwards at the outflow side.The returned crimped valve was then expanded, and the frame was corrected.Leaflets were noted to be wrinkled and dehydrated.This was likely due to the storage condition (prolonged crimping) during the return handling process.A device history record (dhr) review was performed, and it did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was also performed and revealed no other events relating to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 the failure mode is not required at this time.In this case, the valve frame damage was confirmed based on evaluation of the returned device and provided imagery.A review of the dhr, lot history and complaint history did not provide any indication that a manufacturing non-conformance contributed to the event.A review of the ifu/training materials revealed no deficiencies.As reported, "during the valve alignment, it was noticed that one of the valve struts (on the skirt-side) was pointing out approximately 30 degrees in the abdominal aorta".However, it was noted during evaluation of the returned device that the bent strut was observed at the outflow side.In this case, it is possible that one (1) strut interacted with the patient's calcification past the bifurcation resulting in the reported bent strut at the inflow side.Per returned device evaluation, there was no bent strut observed at the inflow side.It is possible that the observed bent strut at the inflow side was corrected during withdrawal of the crimped valve.Per the information provided, there may have been some damage on the system/valve since it was surgically removed, and some pull force was applied during the procedure.Additionally, device evaluation revealed one (1) strut bent outwards at the outflow side, which may suggest excessive device manipulation during system withdrawal.Excessive force applied to manipulate the device during withdrawal can lead to the valve struts interacting with the sheath tip/shaft and/or patient's vasculature, resulting in the observed strut damage at the outflow side.As such, the available information suggests that patient factors (calcification and tortuosity) and/or procedural factors (excessive device manipulation and withdrawal of the crimped valve) may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, 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.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The following sections of this report have been corrected/updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).This is one of two manufacturer reports being submitted for this case.Please reference manufacturer report no: 2015691-2024-00965 for details of the other event.The device was returned to edwards lifesciences for evaluation.Imagery was also provided for evaluation.Review of the provided imagery revealed one (1) bent strut outwards, approximately 30 degrees, at the inflow side prior to valve alignment.It was also noted that the valve struts at the outflow side appeared to have interacted with the sheath tip during withdrawal of the system.The returned device was visually inspected and one (1) strut was observed to be bent outwards at the outflow side.The returned crimped valve was then expanded, and the frame was corrected.Leaflets were noted to be wrinkled and dehydrated.This was likely due to the storage condition (prolonged crimping) during the return handling process.A device history record (dhr) review was performed, and it did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was also performed and revealed no other events relating to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 the failure mode is not required at this time.In this case, the valve frame damage was confirmed based on evaluation of the returned device and provided imagery.A review of the dhr, lot history and complaint history did not provide any indication that a manufacturing non-conformance contributed to the event.A review of the ifu/training materials revealed no deficiencies.As reported, "during the valve alignment, it was noticed that one of the valve struts (on the skirt-side) was pointing out approximately 30 degrees in the abdominal aorta".However, it was noted during evaluation of the returned device that the bent strut was observed at the outflow side.Per the information provided, there may have been some damage on the system/valve since it was surgically removed, and some pull force was applied during the procedure.Additionally, device evaluation revealed one (1) strut bent outwards at the outflow side, which may suggest excessive device manipulation during system withdrawal.Excessive force applied to manipulate the device during withdrawal can lead to the valve struts interacting with the sheath tip/shaft and/or patient's vasculature, resulting in the observed strut damage at the outflow side.Per evaluation of the returned device, there was no bent strut observed at the inflow side.It is possible the observed bent strut at the inflow side was corrected during withdrawal of the crimped valve.In this case, available information suggests that procedural factors (excessive device manipulation and withdrawal of the crimped valve) may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, 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: SAPIEN 3 TRANSCATHETER HEART VALVE
• 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: 18486364
• MDR Text Key: 332572898
• Report Number: 2015691-2024-00256
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/02/2024; 02/13/2024; 03/06/2024
• Supplement Dates FDA Received: 01/22/2024; 03/05/2024; 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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