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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Separation Problem (4043)

Patient Problems Endocarditis (1834); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  Injury  

Event Description

Through implant patient registry it was learned that a 27mm 11500a aortic valve was explanted after an implant duration of 2 years, 3 months due to valve dehiscence with rocking motion and perivalvular leak (pvl).The patient was asymptomatic.The explanted valve was replaced with a 25mm 11060a valved conduit.Per medical records, mobilization around the aortic root revealed an unexpected moderate sized pocket of purulent fluid.The patient showed no symptoms of infection.The operation was performed as if the field was actively infected.The prosthetic valve did not appear obviously infected, but was treated as it was infected.It was partially dehisced around one third of its circumference.The valve was removed.The entire suture line of the valve had dehisced from the true aortic annulus and that there was circumferential pseudoaneurysm separating the aortic annulus and the valve.The annulus was sized to a 25mm 11060a valved conduit and the conduit was implanted.The cross clamp was removed.The patient was weaned from bypass and decannulated.Protamine was administered.There was significant coagulopathy requiring transfusion of multiple blood products.During this time, the patient required significant does of inotropic support, but was experiencing hemodynamic stabilization.Multiple additional bleeding points were addressed and additional blood products were administered and bleeding appeared to improved and the overall situation was stable.Tee demonstrated mildly depressed rv function and normal functioning of the prosthetic aortic valve.Nearly an hour after separation from bypass and decannulation, the patient experience a v-fib arrest requiring internal massage and defibrillation.Finally, an episode of v-fib occurred that did not respond to defibrillation.Given the overall situation, it was clear the patient would not survive a re-institution of bypass or ecmo.Resuscitative attempts were aborted and the patient expired in the or.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.

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

Added information to b5, b6, b7, h6.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Through implant patient registry and investigation, it was learned that a 27mm 11500a aortic valve was explanted after an implant duration of 2 years, 3 months due to valve infection/endocarditis with dehiscence and perivalvular leak.The explanted valve was replaced with a 25mm 11060a aortic valved conduit.Per medical records, the patient presented asymptomatic.Cardiac workup showed aortic root aneurysm with dehiscence and paravalvular regurgitation.The patient underwent redo-avr with bentall procedure - aortic root replacement.The entire suture line of the valve had dehisced from the true aortic annulus and there was circumferential pseudoaneurysm separating the aortic annulus and the valve.There was a moderately sized pocket of purulent fluid that was unexpected since pre-op blood cultures were negative.The prosthetic valve did not appear obviously infected, nonetheless from this point on was treated as infected.The area was thoroughly debrided and irrigated with antibiotic solution.A 25mm 11060a avc was implanted.Post-procedure tee showed normal functioning of the prosthetic aortic valve.There was significant coagulopathy requiring multiple blood products and multiple bleeding points were addressed.The patient continued to bleed and then coded.Despite maximum support and the extent of surgery, it was clear the patient would not survive a re-institution of bypass or ecmo.Resuscitative attempts were aborted, and the patient expired in the or.Per death summary, primary diagnosis was aortic root aneurysm/dissection and probable aortic valve infection with aortic root abscess.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16449708
• MDR Text Key: 310319212
• Report Number: 2015691-2023-11128
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)240527(11)200528217044562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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
• Device Catalogue Number: 11500A27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 94 KG