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

Model Number PVS25

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Insufficiency (1715); Pulmonary Edema (2020)

Event Date 10/29/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1210 , s/n # (b)(4) were retrieved and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.The open and close images from the steady flow test inspection performed on valve sn# (b)(4) demonstrate acceptable opened and closed leaflet performance of the pvs25 sn# (b)(4) valve.No anomalies are observed during the open/close cycle in terms of leaflet coaptation.In particular there is no central hole in the closed image that could be associated with a central leak issue, and in the open image the leaflets are fully opened.The valve therefore meets the acceptance criteria of the steady flow test inspection defined per internal procedure, the principal device function test during manufacture.On receipt of the device gross examination was performed.The returned prosthesis was received blood stained and in general it appeared to be in good condition.In the process returning to manufacturer.

Event Description

A perceval valve size 25 mm was implanted on (b)(6) 2017 via full sternotomy, for replacement of a native stenotic valve.An isolated procedure was performed, guiding sutures were removed.This was the implanting physician's first implant since proctor sign off.Intra-operative tee was ok as per senior surgical fellow,.Post operative echo showed pvl, which was detected 24 hrs after implant.Patient presented with acute pulmonary edema.Re-operation was performed on (b)(6), the perceval was removed and a edwards size l (type unknown) was implanted.Further annular debridement was required to stitch a tissue valve in, but the amount of decalcification done in first instance was appropriate for sutureless valve, as stated by physician that further decalcification could have created a breach in continuity of aorto ventricular continuation.Patient still in hospital recovering (as of (b)(6) update).

Manufacturer Narrative

Visual inspection of the returned valve confirmed the absence of manufacturing defects.Although slightly damaged tissue and non-circular geometry of the inflow side of the valve were observed, these are attributable to the implant/explant procedure.Dimensional analysis using a go-no go test confirmed the absence of dimensional irregularities.Simulation of valve deployment was performed using the returned prosthesis.No problems were encountered during deployment or ballooning of the valve in a silicon aortic root.Even in the presence of the previously mentioned deformation of the valve ring, sealing at the annulus level was confirmed, and it was not possible to replicate the anomalous behavior described in the case history.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic to the involved device.The root cause of the event is therefore undetermined.

Event Description

A perceval valve size 25mm was implanted on (b)(6) 2017 via full sternotomy, for replacement of a native stenotic valve.An isolated procedure was performed, guiding sutures were removed.This was the implanting physician's first implant since proctor sign off.Intra-operative tee was ok as per senior surgical fellow.Post operative echo showed pvl, which was detected 24 hrs after implant.Patient presented with acute pulmonary edema.Re-operation was performed on (b)(6), the perceval was removed and a edwards perimount size l was implanted intra-annularly.Further annular debridement was required to stitch a tissue valve in, but the amount of decalcification done in first instance was appropriate for sutureless valve, as stated by physician that further decalcification could have created a breach in aorto-ventricular continuity.The patient was extubated on itu but was oxygen-dependant.He subsequently went into af and was put on amiodarone.He then developed lung fibrosis, his amiodarone stopped, and he died.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• 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: 7074573
• MDR Text Key: 93450242
• Report Number: 3004478276-2017-00195
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)201211
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/11/2020
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2016
• 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; Hospitalization; Required Intervention