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

Model Number 9600TFX29A

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457)

Patient Problem Hemolysis (1886)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the valve clinic coordinator (vcc), approximately 3 months 20 days post implant of a 29mm sapien 3 valve in the mitral position, tee showed moderate to severe paravalvular leak (pvl).Hematology was consulted and it was believed that hemolysis is being caused by the paravalvular leak.A proctor review was requested by the vcc, and an edwards proctor performed a ct analysis.The ct analysis showed the valve appeared to be too atrial.It was also observed that the outflow of the valve was deformed and under-expanded.Additional images suggest that part of the stent frame was bended inward, or even fractured (unable to confirm), at the posterolateral portion.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.Imagery was provided by the facility and reviewed by an edwards' proctor.Upon review, the following was observed: struts were bent and deformed at outflow, valve 2 was deployed within valve1, and deployed lower than valve 1.Paravalvular leak observed.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.The complaint for frame damage, paravalvular leak and thv migrated was confirmed based on imagery review.It should be noted that the thv was deployed in native mitral valve with mitral annular calcification (mac).The sapien 3 (s3) with the commander delivery system (ds) was indicated for native aortic valve, surgical or transcatheter bioprosthetic aortic valve, surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring replacement only.Therefore, this was off-label operation.As reported, 'approximately 3 months 20 days post implant of a 29mm sapien 3 valve in the mitral position, tee showed moderate to severe paravalvular leak (pvl).The ct analysis showed the valve appeared to be too atrial.It was also observed that the outflow of the valve was deformed and under-expanded'.A viv with 29mm was planned to resolve the pvl issue.During viv, pre-dilation with +5cc was done and during which the balloon ruptured, and it was noticed that there was a fracture of the base of the frame, and the frame piece was swinging.The team went back to review imaging and saw that it was broken prior to dilation.Due to insufficient information, a definitive root cause is unable to be determined.Per the instructions for use (ifu), valve migration requiring intervention is a known potential adverse event associated with transcatheter valve replacement (thv).According to the literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the annulus.Stent valves are subjected to antegrade ejection forces during systole.Less-than-severe and non-uniformly distributed calcification of the leaflets, incorrect bioprosthetic valve sizing, and incomplete frame expansion can contribute to valve migration.Additionally, residual overhanging leaflets can exert downwards force during diastole, causing migration of the thv towards the ventricle.In this case, the thv was implanted in native mitral valve, which is non-circular in shape.As the contact between the thv and the annulus is irregular, anchoring of thv to such landing zones would be inadequate.Additionally, the valve was under expanded which creates inadequate anchoring of the valve to the landing zone and could lead to valve migration.As such, available information suggests procedural factors (off label operation, under-expanded valve) may have contributed to the reported event.In this case, the valve was migrated to atrial, and this factor could have compromised the seal provide by the pvl skirt between the valve and target site leading to pvl.As such available information suggests procedural factors (thv migrated) may have contributed to the complaint event.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 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: 15302933
• MDR Text Key: 298703148
• Report Number: 2015691-2022-07531
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)230722
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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 Expiration Date: 07/22/2023
• Device Model Number: 9600TFX29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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: 84 YR
• Patient Sex: Male