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

Model Number PVS23

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Cardiac Arrest (1762); Cardiogenic Shock (2262)

Event Date 04/24/2015

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

The manufacturer received information about this event through the (b)(6) study database.On (b)(6) 2012, a (b)(6) years old male patient received a perceval pvs23 in aortic position.The procedure was performed in mini-thoracotomy and no concomitant procedures occurred.At discharge, the echo showed a mean gradient of 15mmhg and no central/perivalvular leaks.On (b)(6) 2015, a structural valve deterioration was identified.It is reported that the leaflet appeared stiffened (calcified), resulting in a steno-insufficiency of the device.The patient was symptomatic.About one month later, on (b)(6) 2015, the patient had a cardiogenic shock followed by cardiac arrest.On (b)(6) 2015, a re-intervention occurred due to structural valve deterioration of the device.A valve-in-valve procedure was performed.Prior to the event, the last available information on the device functionality is in (b)(6) 2013; the echo performed showed a mean gradient of 14mmhg and no central/perivalvular leaks.

Manufacturer Narrative

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.

Manufacturer Narrative

Since the device was not explanted, no further device analysis can be performed.As such, the root cause of the event cannot be determined at this time.It could be possible, as also confirmed by the site, that the patient's renal insufficiency contributed to the reported structural valve deterioration.However, this cannot be confirmed due to the limited investigation performed, and the root cause remains ultimately unknown.It should be noted that structural valve deterioration is a known inherent risk associated with cardiac valve replacement with a bioprosthesis, and is listed among the potential adverse events in the perceval instructions for use.

Event Description

The manufacturer received information about this event through the sure avr study database.On (b)(6) 2012, a 71 years old male patient received a perceval pvs23 in aortic position.The procedure was performed in mini-thoracotomy and no concomitant procedures occurred.At discharge, the echo showed a mean gradient of 15mmhg and no central/perivalvular leaks.A good valve functionality was also observed in nov 2013 (mean gradient of 14mmhg, no leaks) on 24 apr 2015, a structural valve deterioration was identified.It is reported that the leaflet appeared stiffened (calcified), resulting in a steno-insufficiency of the device.The patient was symptomatic.About one month later, on (b)(6) 2015, the patient had a cardiogenic shock followed by cardiac arrest.On (b)(6) 2015, a re-intervention occurred due to structural valve deterioration of the device.A valve-in-valve procedure was performed, without any complication.The patient moved to another hospital in good conditions.The site reported that the may have been a relationship between the patient's renal insufficiency and the reported structural valve deterioration.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8392867
• MDR Text Key: 137929810
• Report Number: 3005687633-2019-00155
• 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: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2019

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: Health Professional
• Device Expiration Date: 09/29/2014
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 03/15/2019; 04/17/2019
• Supplement Dates FDA Received: 04/10/2019; 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 67