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

Model Number 11500A25

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

Patient Problem No Code Available (3191)

Event Date 05/03/2019

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.It is unknown if patient and/or procedure related factors may have caused or contributed to this event.There has been no allegation of a product malfunction.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 this 25mm 11500a aortic pericardial valve was explanted after an implant duration of two (2) months due to unknown reason.A 25mm 3300tfx was implanted in replacement.No other details were provided.

Manufacturer Narrative

Additional 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.The root cause of this event cannot be conclusively determined with the available information.However, the event in this case was most likely due to patient related factors.It was noted that a fistula had formed and was believed to be from excess decalcification and the integrity of the patient's tissue.There was no allegation of device malfunction.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

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 this 25mm 11500a aortic pericardial valve was explanted after an implant duration of two (2) months due to paravalvular leak.As reported, a fistula had formed believed to be from excess decalcification and the integrity of the patient¿s tissue.The valve had no bearing on this.There was no allegation of device malfunction.A 25mm 3300tfx was implanted in replacement.Subsequently, the patient expired.Reportedly, it is unsure of the cause of death, but it was definitely not valve related.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8940226
• MDR Text Key: 157047876
• Report Number: 2015691-2019-03216
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2020
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 70 YR