MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS23

Device Problem Difficult to Open or Close (2921)

Patient Problems Pleural Effusion (2010); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

The manufacturer was notified of the following publication involving a perceval s sutureless aortic heart valve: hypo-attenuated leaflet thickening and reduced leaflet motion after the implantation of the perceval s sutureless bioprosthesis.The paper reports the following case study.A (b)(6)-year-old woman with dyspnea was diagnosed with severe triple-vessel coronary artery disease and moderate aortic stenosis (aortic valve area 1.2 cm2).The patient presented with a reduced left ventricular ejection fraction (lvef) of 43%.The patient¿s comorbidities included hypertension, dyslipidemia, diabetes mellitus and interstitial pneumonia, which had been medically managed.The society of thoracic surgeons predicted risk of mortality score was 9.5%.The patient had no history of clotting abnormalities or thrombosis and a regular preoperative blood examination showed the patient had normal coagulation and fibrinolytic capacity.The patient underwent quintuple coronary artery bypass grafting and sutureless avr with a perceval s bioprosthesis, size m (livanova plc, london, uk), and had an uneventful postoperative course.The antithrombotic protocol comprised of aspirin (l00 mg/day) and warfarin with a prothrombin international normalized ratio (pt-inr) between 2.0 and 2.5.Postoperative echocardiography on day #4 revealed an lvef of 36%, a normal functioning perceval valve, and a mean pg of 10 mmhg with no paravalvular leakage.As the postoperative recovery was slow with persistent pleural effusion, follow-up echocardiography was conducted on day #17, and revealed an increased mean pg of 19 mmhg and a worsening lvef of 26%.Cardiac computed tomography (ct) was subsequently performed, which showed thrombus formation that affected two leaflets.Pharmacotherapy for thrombus resolution was initiated with systemic heparinization (activated partial thromboplastin time 50¿80 s), in addition to continuing warfarin for 3 weeks.Follow-up ct and echocardiography showed complete resolution of halt, mean pg of 8 mmhg, and lvef of up to 36%.The patient did not show any neurological symptoms after surgery and was uneventfully discharged home on day #55.

Event Description

Per additional information received, it was reported that at follow up (pod 17), mild pvl was observed.Ct showed halt and slightly tilted valve low at ncc.All saphenous vein grafts (except for lita) were also occluded.The halt and pvl resolved at 6 month follow up.The device was not explanted and there is no plan for re-intervention.The remainder of the information previously submitted remains unchanged.

Manufacturer Narrative

The manufacturer received additional information on this event including the device serial number.A review of the device history records is currently being performed and an update will be provided upon completion.Since the device remains implanted, no further investigation can be performed.

Manufacturer Narrative

Additional information gathered from the site indicated the following: the event was thought to be related to the patient¿s unique blood coagulation ability, as all four bypass graft were also clogged.No other information was provided about the treatment provided to correct the mal-positioning, if tilting was resolved, if there any other consequences/impact/ treatment for the patient, nor if there was any medical judgment provided on the suspected cause leading to the events (halt/thrombosis and tilting/pvl).However the site did not consider this case to be a product complaint.As such, no further investigation is warranted and the case will be deemed closed at this time.

Event Description

Additional information gathered from the site indicated the following: the event was thought to be related to the patient¿s unique blood coagulation ability, as all four bypass graft were also clogged.No other information was provided about the treatment provided to correct the mal-positioning, if tilting was resolved, if there any other consequences/impact/ treatment for the patient, nor if there was any medical judgment provided on the suspected cause leading to the events (halt/thrombosis and tilting/pvl).However the site did not consider this case to be a product complaint.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10787834
• MDR Text Key: 214650156
• Report Number: 3004478276-2020-00228
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR