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

Model Number	8300AB
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: 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 one (1) year, three (3) months.There was no reported malfunction of the device.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 allegation of device 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.
Event or Problem Description
Through implant patient registry, it was reported that a 27mm 8300ab aortic valve was explanted after an implant duration of one (1) year, three (3) months due to moderate-severe perivalvular leak (pvl).The explanted valve was replaced with a 29mm 3300tfx aortic valve.The implantation data card indicated that the device explant was not due to deficiency of the original device.Per medical records, the perivalvular leak was identified between the right and noncoronary cusp.The 27mm valve and amplatzer septal occluders x2 were explanted and replaced with a 29mm 3300tfx aortic valve.A mv repair with a non-edwards annuloplasty ring was also performed.Postoperative tee revealed excellent valve function with no significant pvl.The patient tolerated the procedure well and was transferred to the icu in stable condition.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H11: corrected data: corrected section h6 (investigation findings, investigation conclusions).

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11447232
• Report Number: 2015691-2021-01767
• Device Sequence Number: 17024973
• Product Code: LWR
• UDI-Device Identifier: 00690103194517
• UDI-Public: 00690103194517
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 81 YR