MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; TISSUE, HEART-VALVE

Model Number 11500A

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Death (1802); Cardiogenic Shock (2262)

Event Date 09/03/2020

Event Type  Death  

Manufacturer Narrative

Additional manufacturer narrative: 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.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.In this case, the patient required intervention due to perivalvular leak after the aortotomy was closed. the root cause of this event cannot be conclusively determined with the available information.The explanted device is not available for evaluation.It is unknown whether patient and/or procedural related factors may have caused or contributed to the reported issue.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

Through the implant patient registry, it was learnt that a 21mm 11500a inspiris valve was explanted at implant due to pvl.The explanted valve was replaced with a 21mm 11500a inspiris valve.The procedure was complicated by prolonged cpb and cross-clamp time resulting in cardiogenic shock requiring placement of iabp and transition from cpb to central va ecmo with an open chest.The patient expired on pod # 1.Per received medical records, the patient presented with nonrheumatic as, and multivessel cad and underwent avr+cabgx3.The 21mm 11500a aortic valve was implanted.One suture pulled through the tissue while tying.The valve was gently reflected back to expose this area and a pledgetted suture was placed to replace this suture and reinforce the area.The valve was again lowered and inspected for perfect seating.The aortotomy was closed and the aortic cross-clamp was removed.Tee showed paravalvular leak.The aortotomy was reopened and the valve was inspected.There was no obvious defect but the valve and sutures were removed.A new 21 mm resilia aortic valve was implanted well beneath the coronary ostia.When attempted to wean from bypass, a significant rv and lv dysfunction was encountered.An iabp was placed and the patient was transitioned from bypass circuit to central va ecmo.The patient tolerated the procedure well and was transported to the cardiac intensive care unit in critical but stable condition.The postoperative course was complicated by coagulopathy, profound acidosis, acute renal failure, shock liver and cardiac tamponade.On pod#1, the patient was emergently returned to the or for chest washout, rv repair, and hemodialysis initiation.After discussing the patient's condition with his family, they elected to withdraw care.The patient became asystolic and expired on pod #1.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.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10649561
• MDR Text Key: 210424313
• Report Number: 2015691-2020-13878
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR