MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB

Device Problem Perivalvular Leak (1457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Udi #(b)(4).Multiple requests for additional information; however, the healthcare provider was unable to provide further details.The root cause of this event cannot be determined with the available information.There has been no allegation of a product malfunction.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

It was reported that a patient with a 21mm 8300ab aortic pericardial valve, implanted for six (6) months, exhibited a large paravalvular leak on tee.Treatment was discussed with the patient; however, the patient failed to continue his follow-up appointment.The physician indicated that he has no further information.

Manufacturer Narrative

H11: corrected data: corrected section h6.

Event Description

It was reported that a patient with a 25mm 8300ab aortic pericardial valve was explanted after an implant duration of seven (7) months due to a large paravalvular leak (pvl) on tee.As reported, in order to remove the valve, the surgeon had to distort the stent frame.After removing, the stent cage was expanded back out.The pvl appeared to be between the left and right cusps in the anterior portion of the valve.It was easily visible as there was a gap at the commissure stent post.It did not appear that the valve was defective or damaged and the doctor did not believe that.He stated that there was no apposition at that point, causing the leak.A 25mm 11500a aortic valve was implanted successfully and the leak was resolved.

Manufacturer Narrative

Intraop tee evaluation: reportedly, seven (7) months after aortic valve replacement with a 25mm 8300ab pericardial aortic valve, tee reveals evidence of significant (moderate or severe) paravalvular aortic regurgitation.As visualized, the aortic bioprosthesis appears otherwise normal.H11: corrected data: corrected sections d4: udi # (b)(4).Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.While the majority of affected patients are asymptomatic, pvl, when severe, can lead to significant morbidity including heart failure and hemolytic anemia.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Under sizing can lead to a gap between the annulus and sewing ring since the valve implanted is too small in relation to the annulus.The use of pledgeted sutures during aortic valve replacement was thought to decrease the incidence of pvl.However, recent studies have concluded that non-pledgeted suture techniques offer an equivalent alternative to the traditional use of pledgets during aortic valve replacement, with no increase in pvl rates.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.The annulus is not a static structure and has dynamic characteristics which have been shown to play a critical role in valve function and efficiency.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards' valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.In this case, the patient required intervention due to perivalvular leak after an implant duration of seven (7) months.The root cause of this event cannot be conclusively determined with the available information.It is unknown whether patient and/or procedural related factors may have caused or contributed to the reported issue.The subject device was not returned for evaluation as there was no reported malfunction of the device.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a patient with a 25mm 8300ab aortic pericardial valve was explanted after an implant duration of seven (7) months due to a large paravalvular leak (pvl) on tee and inadequate coaptation per the pathology report.As reported, in order to remove the valve, the surgeon had to distort the stent frame.After removing, the stent cage was expanded back out.The pvl appeared to be between the left and right cusps in the anterior portion of the valve.It was easily visible as there was a gap at the commissure stent post.It did not appear that the valve was defective or damaged and the doctor did not believe that.He stated that there was no apposition at that point, causing the leak.A 25mm 11500a aortic valve was implanted successfully and the leak was resolved.Internal md intra-op tee review: reportedly 7 months after aortic valve replacement with a 25 mm model 8300ab pericardial aortic valve, tee reveals evidence of significant (moderate or severe) paravalvular aortic regurgitation.As visualized, the aortic bioprosthesis appears otherwise normal.

Manufacturer Narrative

H10: additional manufacturer narrative: updated section d10, h3.The explanted valve has been returned for evaluation.Device evaluation anticipated, but not yet begun.A supplemental report will be submitted once the evaluation has been completed.H11: corrected data: corrected section b5.

Manufacturer Narrative

H3: evaluation summary: customer report of pvl was confirmed through attached tee review report.As received, black mold-like particulates were found on the surfaces of leaflets 1 and 3 on the outflow aspect and on leaflet 2 on the inflow aspect; particulates were easily wiped away.Leaflet 1 had non-transmural leaflet tear, approximately 5mm long, at the cusp area and a serrated mechanical damage mark near commissure 2.X-ray demonstrated wireform intact and frame expanded.Host tissue on the stent circumference was moderate at the inflow aspect and minimal at the outflow aspect.Sewing ring was cut around leaflet 2.No other visible inconsistencies were observed on the valve.Suture holes were visible near all three black stitch markings on the sewing ring; one suture hole near each.Wireform was exposed on commissure 3.Photos provided were not consistent with lab findings; black mold-like particulates were not present on the valve photos provided.Valve frame appeared deformed inward in one of the photos provided and valve frame appeared expanded in another photo.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.While the majority of affected patients are asymptomatic, pvl, when severe, can lead to significant morbidity including heart failure and hemolytic anemia.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Under sizing can lead to a gap between the annulus and sewing ring since the valve implanted is too small in relation to the annulus.The use of pledgeted sutures during aortic valve replacement was thought to decrease the incidence of pvl.However, recent studies have concluded that non-pledgeted suture techniques offer an equivalent alternative to the traditional use of pledgets during aortic valve replacement, with no increase in pvl rates.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.The annulus is not a static structure and has dynamic characteristics which have been shown to play a critical role in valve function and efficiency.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards' valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.In this case, the patient required intervention due to perivalvular leak after an implant duration of seven (7) months.The root cause of this event cannot be conclusively determined with the available information.However, it is likely that procedural related factors may have caused or contributed to the reported issue.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10479743
• MDR Text Key: 206376726
• Report Number: 2015691-2020-13394
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 10/07/2020; 10/28/2020; 11/03/2020
• Supplement Dates FDA Received: 09/29/2020; 10/08/2020; 11/02/2020; 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR