MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9300TFX26

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(4) affiliate, approximately 4 years and nine months post implantation of a sapien xt valve in the aortic position, a 2nd sapien 3 valve was implanted due to signs of stenosis and regurgitation.An echo revealed trace paravalvular leak (pvl). the patient¿s peak gradient measured 62mmhg and mean gradient 36mmhg with an aortic valve area of 0.8cm2.As reported, at the time of implant, of the sapien xt valve, the valve was implanted too high in the annulus (too aortic) which resulted in moderate pvl; however, did not progress over the years.Per report, the valve was not placed to high purposely, the valve traveled during deployment.

Manufacturer Narrative

Additional information added to b5 (describe event or problem).The sapien xt valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.There was no photo or imaging provided.During manufacturing the valve is inspected and tested throughout the process.The manufacturing mitigations are in place at edwards lifesciences to ensure all sapien xt valves meet the valve specification.The leaflet components undergo inspections for leaflet thickness, the leaflets are 100% tested, the cut leaflets are dimensionally inspected on sampling basis and the cut leaflets are 100% visually inspected for mechanical defects (e.G.Separation, ragged edges, torn tissue, thin spots, and wrinkles).During the production flow testing, the coaptation test is performed.Valves are 100% visually inspected before and after being attached to holder.These manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.A device history record (dhr) was performed and did not reveal any manufacturing non-conformance issues that would have contribute to the complaint event.The ifu for sapien xt with novaflex+ was reviewed for instructions relating to the complaint event.Long-term durability has not been established for the thv.Regular medical follow-up is advised to evaluate valve performance.In addition to the risks listed above, additional potential risks specifically associated with aortic valve replacement and bioprosthetic heart valves include, but may not be limited to, the following: structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent post, leaflet retraction, suture line disruption of components of a prosthetic valve, chordal rupture, thickening, stenosis, or other); valve stenosis.Based on the review of the ifu and training manual, 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.The complaint was unable to be confirmed.A review of the dhr revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of manufacturing mitigations supports that the sapien xt valve had proper inspections in place to detect issues related to the complaint events.A review of ifu/training revealed no deficiencies.During the manufacturing process, all sapien xt valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including calcification, support structure deformation (out-of-round configuration), trauma (cardio-pulmonary resuscitation, blunt chest trauma), and native leaflet prolapse impeding prosthetic leaflet motion.Stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.There are cases of svd that result in a combination of regurgitation and stenosis.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.In this case, a conclusive root cause was unable to be determined at this time.However, patient/procedural factors may have contributed to the reported event.No manufacturing nonconformances that would have contributed to the reported events were identified.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.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.No labeling/ifu deficiencies were identified.Therefore, no corrective or preventative action no product risk assessment is required at this time.

Event Description

Of note, the patient had follow up visit post procedure and the gradients have decreased post implant.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11100969
• MDR Text Key: 224596489
• Report Number: 2015691-2020-15340
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2016
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EDWARDS 26MM NOVAFLEX DS, 16FR ESHEATH; EDWARDS 26MM NOVAFLEX DS, 16FR ESHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR