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

Model Number PVS23

Device Problems Leak/Splash (1354); Incomplete Coaptation (2507); Folded (2630)

Patient Problem Aortic Insufficiency (1715)

Event Date 01/23/2017

Event Type  Injury  

Event Description

The patient underwent implantation of a size medium perceval valve for aortic valve replacement through an upper partial sternotomy.After implantation it was noticed that the non-coronary leaflet had a small folding on the leaflet.The patient went off bypass and on transesophageal echocardiogram, they could see a small intervalvular insufficiency.They decided to leave the valve implanted as they believed the central leakage would go back to normal after the valve had had time to adapt.After three days an echo showed an increase in the insufficiency and the patient had clear symptoms of dyspnea and an increase in pro-bnp.The surgeon decided to re-operate and during the reoperation they would see that the non-coronary leaflet did not work at all.It was stiff and not coapting with the other leaflets.The valve was replaced with another perceval valve of the same size after new measurements were taken.The new valve was working perfectly and the rest of the hospital stay was uneventful.

Manufacturer Narrative

Device received for analysis on (b)(6) 2017.Gross exam was completed (b)(6) 2017.

Event Description

Additional information was received on (b)(6) 2017 that the guiding sutures on the device were in fact removed from the device.

Manufacturer Narrative

The complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The transthoracic echocardiogram from (b)(6) 2017 was received and reviewed by external consultants.The study is of very limited quality (poor images and limited views).Mean and peak gradients seem to be unremarkable (8/12 mmhg).Doppler velocity index is normal at 0.5.There is mild aortic regurgitation, cannot determine if central or paravalvular, nor the underlying mechanism.The visual inspection performed on the returned prosthesis confirmed the absence of manufacturing defects.The hydrodynamic testing conducted on the returned prosthesis confirmed that the device was showing normal leaflet kinematics with regurgitation fraction in compliance with requirement of en iso 5840:2015.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.

Manufacturer Narrative

On (b)(6) 2017 ¿ tte ¿ the study is of very limited quality (poor images and limited views).There is a bioprosthetic aortic valve in place.Mean and peak gradients seem to be unremarkable (8/12 mmhg).Doppler velocity index is normal at 0.5.There is mild aortic regurgitation, cannot determine if central or paravalvular, nor the underlying mechanism.A tee could help describe this better.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.

Event Description

Information was provide that the guiding sutures were removed and the decalcification was done properly.Looking at the explanted prosthesis, one of the cusps is, due to its abnormal shape, creating an incomplete ¿mercedes sign¿, restricting the haemodynamics.Thus, the surgeon believes this fabrication issue is what causes the central leakage.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada per crescentino,; saluggia
• Manufacturer (Section G): SORIN GROUP ITALIA; strada per crescentino, sn; saluggia
• Manufacturer Contact: francesca crovato ; 5005 fraser north way; burnaby, bc
• MDR Report Key: 6386980
• MDR Text Key: 69351838
• Report Number: 3005687633-2017-00014
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 07/10/2017

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: 02/16/2019
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/29/2017
• Supplement Dates FDA Received: 04/07/2017; 06/22/2017; 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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: 77 YR