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

Model Number 8300AB25

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); No Code Available (3191)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts to obtain additional information and for product return has been made.There has been no response at this time.There is currently insufficient information to determine the root cause of this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

Event Description

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.It was reported that a 25mm pericardial aortic valve was explanted after an implant duration of approximately one (1) year due to unknown reasons.The explanted valve was replaced with a 27mm pericardial aortic valve.No other details were provided.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

Event Description

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.It was reported through the implant patient registry that a 25mm pericardial aortic valve was explanted after an implant duration of approximately one (1) year due to severe aortic regurgitation and paravalvular leak.The explanted valve was replaced with a 27mm edwards pericardial aortic valve.Post operatively, the patient developed symptomatic complete heart block and severe bradycardia requiring a permanent pacemaker implant.Per the medical records, an oblique arteriotomy was made, extending from the noncoronary sinus to the aortic root.The aortic valve was explanted.Calcium was debrided off the aortic annulus and the annulus was sized to a 27mm valve.Sutures were placed with pledgets down the ventricular side in a horizontal mattress style circumferentially around the aortic valve annulus.The sutures were passed through the sewing ring of a 27mm aortic valve.The valve was seated in the subvalvular space.After ensuring that no suture was trapped, the sutures were secured in position with the cor-knot device.The patient was gradually weaned from cardiopulmonary bypass.The patient was transported to the icu in satisfactory condition.Post operatively, the patient developed symptomatic complete heart block and severe bradycardia requiring a permanent pacemaker implant on pod #6.The patient was discharged to a skilled nursing facility on pod #7 in stable condition.

Manufacturer Narrative

Aortic regurgitation (ar) in bioprosthetic heart valves, also known as aortic insufficiency, occurs when the valve does not close properly in diastolic phase, which results in retrograde flow of blood into the left ventricle.Trivial/trace to mild amounts of ar are not unusual post operatively in bioprosthetic valves.This is usually tolerated by the patients.Like mr, if the regurgitation worsens or becomes symptomatic, reoperation may be necessary.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.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 regurgitation and pvl after an implant duration of one (1) year.The 25mm valve was explanted and a 27mm valve was implanted in replacement.The root cause of this event cannot be conclusively determined with the available information.However, regurgitation and pvl in this event were likely due to procedural related factors.Attempts were made to obtain the subject device for evaluation; however, there has been no response.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.

Manufacturer Narrative

Reference capa-20-00141.

• 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: 7833037
• MDR Text Key: 118784809
• Report Number: 2015691-2018-03616
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2018

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 Expiration Date: 04/29/2021
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 09/20/2018; 07/23/2020
• Supplement Dates FDA Received: 09/18/2018; 09/27/2018; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR