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

Model Number 8300

Device Problems Complete Blockage (1094); Gradient Increase (1270)

Patient Problems Thrombosis (2100); Heart Failure (2206); Patient Problem/Medical Problem (2688); Test Result (2695)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) was unable to be reviewed as the device serial number was not provided.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Through review of an article, it was learned that two (2) years after the implantation of an edwards valve, a (b)(6) year old patient presented with suspected valve thrombosis leading to worsening heart failure, severe thrombocytopenia with negative hemocultures.Transthoracic echocardiography (tte) on admission showed symmetrically thickened leaflets of the valve , maximum pressure gradient of 49mmhg, estimated aortic valve area (ava) of 0.6cm2 and lvef of 26%.Low molecular weight heparin (lmwh) treatment was initiated.After 2 weeks of therapy, the leaflets appeared less thickened, with maxpg of 23mmhg and ava of 1.1 cm2 and after additional 3 months of therapy the patient was asymptomatic with normal leaflets, maxpg of 18mmhg, ava of 2.1 cm2 and lvef of 33%.The valve remained implanted.Conclusion: the described case of valve thrombosis indicates that immediate lmwh treatment may reduce the need for surgical intervention in such patients.Additionally, long-term anticoagulation therapy may be needed in elderly patients with low ef and an implanted valve.

Manufacturer Narrative

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.

Event Description

Through review of an article by authors martina krajnc et al, it was learned that two (2) years and one (1) month after the implantation of a 25mm valve, a (b)(6) patient presented with suspected valve thrombosis leading to worsening heart failure and severe thrombocytopenia with negative hemocultures.Transthoracic echocardiography (tte) on admission showed symmetrically thickened leaflets of the valve, maximum pressure gradient (maxpg) of 49mmhg, estimated aortic valve area (ava) of 0.6cm2 an lvef of 26%.Low molecular weight heparin (lmwh) treatment was initiated.After 2 weeks of therapy the leaflets appeared less thickened, with maxpg of 23mmhg and ava of 1.1 cm2 and after additional 3 months of therapy the patient was asymptomatic with normal leaflets, maxpg of 18mmhg, ava of 2.1 cm2 and lvef of 33%.The valve remained implanted.As per follow-up with the surgeon, it was learned that at the time of the implant of this valve, the patient also received a 30mm edwards mitral annuplasty ring in pulmonic position.After the implant surgery the patient received anticoagulation therapy, warfarin (for inr of 2,5-3,5) and aspirin protect 100 mg, for 3 months and after that only aspirin without anticoagulation therapy.The surgeon could find any evidence of this patient having thrombocytopenia before thrombus detection.The possible causes for the trobocytopenia could have been due to thrombosis or due to suspected mielodysplastic syndrome however it was pointed out that as the lmwh treatment was started, the level went up and was normal two months later.Patient's relevant medication at the time of the valve thrombosis diagnosis was receiving aspirin.

Manufacturer Narrative

Corrected data: f10, h6.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: 7911964
• MDR Text Key: 121851308
• Report Number: 2015691-2018-03936
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2017
• Device Model Number: 8300
• 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): Required Intervention
• Patient Age: 79 YR