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

Model Number PVS23

Device Problem Gradient Increase (1270)

Patient Problems Aortic Valve Stenosis (1717); Death (1802); Septic Shock (2068); Hypernatremia (2242); Complete Heart Block (2627); Multiple Organ Failure (3261)

Event Date 03/13/2018

Event Type  Death  

Manufacturer Narrative

No autopsy performed.

Event Description

On (b)(6) the patient had elective aortic valve replacement surgery for a moderately calcified aortic valve.The surgeon used the perceval valve for the first time where an official proctor provided education and guidance prior and during the surgery.Intraoperative tee confirmed the presence of well seated valve with no paravalvular leak.Patient had a peak gradient of 9 mmhg and a mean of 3 mmhg post-replacement.The patient remained hemodynamically stable and was transferred to the icu for further management in a stable condition.On follow up the surgeon reported that the patient was at first pacemaker dependent and then on (b)(6) the patient recovered to sinus rhythm.A report of post-operative tee performed (b)(6) 2018 identified the following.Abnormally functioning bio prosthetic aortic valve with severe stenosis of the prosthetic aortic valve.A peak/mean gradient of 84 mmhg/44 mmhg and a dvi of 0.23.No regurgitation of the prosthetic aortic valve detected.The aortic valve leaflet appeared significantly thickened compared to the intraoperative tee.There was an echogenic mass seen on the ventricular side of the left coronary cusp measuring 0.5 cm in length which could represent a vegetation.The mitral valve leaflets are mildly thickened with moderate mitral regurgitation.A small, mobile vegetation attached to the anterior mitral valve leaflet was identified.The tricuspid valve appeared structurally normal.Moderate tricuspid regurgitation present.The right ventricular systolic pressure, as measured by doppler, is 48 mhg, assuming an rap of 10 mmhg.Mild pulmonary hypertension was identified.The postoperative course was complicated with 2 reintubations, septic shock, acute kidney injury, dic, complete heart block, fluid overload, hypernatremia and ards.On (b)(6) 2018, the patients overall status deteriorated and they developed multiorgan failure.The patient was withdrawn from life support per family request.No autopsy was performed.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4).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.

Manufacturer Narrative

Based on the information provided no specific cause of death was identified and a hypothesis suggesting the root cause was not established.The device history record review did not highlight any anomalies and because the device was not explanted no further investigations are possible.The patients clinical history was not indicated and therefore the multiple failures that lead to the patients death cannot be directly related to any pre-existing conditions.At this time the root cause of the event and the device relationship to the reported adverse event is unknown.If further information regarding the event is received the manufacturer will reassess the case.

Event Description

On (b)(6) the patient had elective aortic valve replacement surgery for a moderately calcified aortic valve.The surgeon used the perceval valve for the first time where an official proctor provided education and guidance prior and during the surgery.Intraoperative tee confirmed the presence of well seated valve with no paravalvular leak.Patient had a peak gradient of 9 mmhg and a mean of 3mmhg post-replacement.The patient remained hemodynamically stable and was transferred to the icu for further management in a stable condition.On follow up the surgeon reported that the patient was at first pacemaker dependent and then on (b)(6) the patient recovered to sinus rhythm.A report of post-operative tee performed (b)(6) 2018 identified the following.Abnormally functioning bio prosthetic aortic valve with severe stenosis of the prosthetic aortic valve.A peak/mean gradient of 84mmhg/44mmhg and a dvi of 0.23.No regurgitation of the prosthetic aortic valve detected.The aortic valve leaflet appeared significantly thickened compared to the intraoperative tee.There was an echogenic mass seen on the ventricular side of the left coronary cusp measuring 0.5 cm in length which could represent a vegetation.The mitral valve leaflets are mildly thickened with moderate mitral regurgitation.A small, mobile vegetation attached to the anterior mitral valve leaflet was identified.The tricuspid valve appeared structurally normal.Moderate tricuspid regurgitation present.The right ventricular systolic pressure, as measured by doppler, is 48mhg, assuming an rap of 10mmhg.Mild pulmonary hypertension was identified.The postoperative course was complicated with 2 reintubations, septic shock, acute kidney injury, dic, complete heart block, fluid overload, hypernatremia and ards.On (b)(6) 2018, the patients overall status deteriorated and they developed multiorgan failure.The patient was withdrawn from life support per family request.No autopsy was performed.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7491471
• MDR Text Key: 107503963
• Report Number: 3004478276-2018-00183
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)211027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2018

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: Lay User/Patient
• Device Expiration Date: 10/27/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/18/2018; 06/17/2018
• Supplement Dates FDA Received: 06/18/2018; 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• 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): Death