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

Model Number SAPIEN VALVE UNKNOWN

Device Problems Calcified (1077); Incomplete Coaptation (2507)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

The implanted valve models and sizes are unknown.Possible valve used - edwards sapien transcatheter heart valve - pma p110021, or the edwards sapien xt transcatheter heart valve - pma p130009.Valve stenosis is listed in the instruction for use (ifu) as a potential risk associated with the use of the thv.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including pannus, calcification, support structure deformation (out-of-round configuration), trauma, endocarditis, prosthetic valve thrombosis, 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.However, it is possible patient factors such as metabolic issues contributed to the valve stenosis.A very common failure mode is tissue calcification.The mechanisms for bioprosthetic heart valve tissue calcification are not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case, based on the limited information provided, the exact root cause and timing of the valve stenosis could not be confirmed.In addition to the mechanisms listed above, the stenosis may be related to patient's co-morbidities not provided or pre-existing valvular disease process may have contributed to the event.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Reference for article: ferreira-neto an, rodriguez-gabella t, guimaraes l, freitas-ferraz a, bernier m, figueiredo guimaraes c, pasian s, paradis jm, delarochelliere r, dumont e, mohammadi s, kalavrouziotis d, cote m, pibarot p, rodes-cabau j.Multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up.Rev esp cardiol (engl ed).2020 apr 8:s1885-5857(20)30043-8.English, spanish.Doi: 10.1016/j.Rec.2020.02.002.Epub ahead of print.Pmid: 32278660.This is one of eight manufacturer reports being submitted for this case.

Event Description

As reported by our affiliate in (b)(6) and through an article: 'multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up', data from 212 patients who underwent transcatheter aortic valve replacement with sapien valves (n=170) and sapien xt valves (n=125) in a single center between 2007 and 2012 was analyzed.Patients had a clinical and echocardiography follow-up at 1 month and 12 months, and yearly thereafter.The following event was identified related to postprocedural complications and follow up: valve stenosis occurred in 11 study patients.Information regarding type and degree of regurgitation and possible intervention was not provided.

Manufacturer Narrative

Additional information: section h10: narrative text.This is one of seven manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-01425, manufacturer report no: 2015691-2021-01427, manufacturer report no: 2015691-2021-01429, manufacturer report no: 2015691-2021-01438, manufacturer report no: 2015691-2021-01443, manufacturer report no: 2015691-2021-01448.

Manufacturer Narrative

The complaint was not able to be confirmed.Due to the unavailability of the devices and/or relevant imagery, engineering was unable to perform any visual, functional, or dimensional analysis.A review of the dhr and lot history could not be performed due to serial number unavailability.A review of manufacturing mitigations supports that proper inspections are in place during the manufacturing process to detect issues relating to the complaint.Review of ifu/training manuals revealed no deficiencies.During the manufacturing process, all sapien and 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 degeneration/deterioration is a potential risk associated with bioprosthetic heart valves.Per the valve academic research consortium (varc), valve degeneration/deterioration 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.The devices were not returned for evaluation as all devices remains implanted in the patients.No further information was provided despite multiple attempts to obtain additional information.In this case, the cause for the valve degeneration/deterioration could not be determined based on the limited available information provided.As such, a definitive root cause was unable to be determined at this time.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.

• Brand Name: EDWARDS SAPIEN VALVE UNKNOWN
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11376206
• MDR Text Key: 233466263
• Report Number: 2015691-2021-01430
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2021

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: SAPIEN VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/03/2021; 04/10/2021
• Supplement Dates FDA Received: 03/03/2021; 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other