MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problems Aortic Regurgitation (1716); Atrial Fibrillation (1729); Congestive Heart Failure (1783); Hemorrhage/Bleeding (1888); Thrombus (2101); Tricuspid Regurgitation (2112); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Complete Heart Block (2627)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.The cause of the event cannot be determined at this time.Attempts to retrieve additional information is in process.If additional information is received a supplemental mdr will be submitted.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.In this case, edwards implant patient registry received information a 25mm aortic valve was explanted after five months due to severe paravalvular leak and apical migration of valve.Patient with longstanding untreated non ischemic cardiomyopathy (ef 10-15%) admitted with cardiogenic shock with recent history of paroxysmal atrial fibrillation and hypertension.Patient presented with acute on chronic congestive heart failure.Tte showed intuity valve seated below the aortic annulus and extending into the lvot.The explanted device was replaced with a 25mm aortic pericardial valve.The patient also underwent tricuspid valve repair with an edwards ring and implant of lvad during the procedure.The patient was transferred back to the surgical icu in stable condition.On post-operative day one it was noted the patient's bleeding significantly decreased; however, does have some flow implications on the lvad device.Echocardiogram revealed an anterior clot which appeared to be restrictive.The patient was discharged on post operative day 25.

Manufacturer Narrative

H10 additional manufacturer narrative: post-operative valve embolization events are a late sign of dehiscence, and may occur as a result of successive dilatation of cardiac structures in combination with friable tissue.These events require intervention.In this case, pvl was noted on pod#: 8 which might have caused or contributed to the valve embolization.Although the product was not returned and there is an allegation of a malfunction, embolization of the valve into the ventricle is most commonly related to patient and/or procedural factors and is not a result of a manufacturing non-conformance.In this case, the pvl most likely occurred due to the device migration.Based on the information provided, a definitive root cause of the device migration could not be conclusively determined, but there¿s no evidence to suggest an edwards manufacturing defect or a product failure (with regard to design, reliability, or use error).Udi number: (b)(4).

Event Description

Pre-operatively to the index procedure, this patient had severe as, severe chf and cardiomyopathy (ef 28%), with mild tr and mr.Intraoperative complications included intraoperative iabp and ventricular arrhythmias.Post-operative complications included new onset atrial fibrillation that eventually converted to sr with 1° av block.Eight days post implant, an echocardiogram detected normal aortic valve function with mild-moderate peri-prosthetic valve regurgitation.The patient was discharged to an extended care facility on post-operative day 13.On day ten of this admission, the explanted device was successfully replaced with a 25mm aortic valve.Concomitantly, the tricuspid valve was repaired with a ring, and an lvad device was placed as a palliative measure.On post-operative day one, the patient returned to the or to treat cardiac pre-tamponade due to bleeding from the anterior pacemaker lead.The patient was discharged from the hospital on post-operative day 26.

Manufacturer Narrative

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

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9801804
• MDR Text Key: 188403065
• Report Number: 2015691-2020-10844
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036/S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: 8300AB
• 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): Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Weight: 76