MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS23

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 09/17/2017

Event Type  Injury  

Manufacturer Narrative

Device available but not yet received.

Event Description

An isolated avr was performed in which a perceval was to be implanted.The patient had an annulus of 21 mm (confirmed by tee in the or), and a medium perceval (pvs23) was selected.According to the customer narrative, the valve was selected according to the sizer: the small sizer passed through the annulus easily, while the medium appeared to be the appropriate choice.Prior to implant, the physician commented that the leaflets lengths were asymmetrical.After implant, echo revealed severe paravalvular and central leakage.A colleague was contacted for assistance, who thought that there was residual calcium in the annulus and that the valve was implanted superiorly.The physician agreed but he and his team still thought that there was a deficit with the perceval.The perceval was removed and due to no stock of medium size, a 19 mm magna ease suture valve was implanted.Per observation by sales, the magna ease appeared to be implanted intra-annularly.It was reported that 30-40 minutes of cross-clamp time was added as a result of the event, and the patient is doing well.The physician successfully implanted 7 perceval valves prior to this event.

Manufacturer Narrative

On oct 23, 2017, a complete manufacturing and material records review for the perceval valve was performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.On oct 27, 2017, the device was received for analysis.Gross examination revealed that the returned valve was received in generally good condition.

Manufacturer Narrative

Visual inspection of the returned valve confirmed the absence of manufacturing defects.Hydrodynamic testing conducted on the returned perceval 23/m heart valve prosthesis sn (b)(4) confirmed that the device exhibited normal leaflet kinematics.No anomalies were observed during the open/close phases of the pulsatile hydrodynamic test.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic to the involved device.Furthermore, according to the event narrative provided, the valve was observed to have residual calcium in the annulus, and was implanted superiorly.As such, this event may be attributable to user technique and a failure to follow instructions, given that the perceval instructions for use mandates that "eccentric/bulky protruding intra-luminal calcifications must be removed".

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6952439
• MDR Text Key: 89414900
• Report Number: 3005687633-2017-00102
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: 12/04/2017

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: Physician
• Device Expiration Date: 05/19/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 10/23/2017; 11/23/2017
• Supplement Dates FDA Received: 11/20/2017; 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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): Required Intervention
• Patient Age: 63 YR