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

Model Number PVS25

Device Problem Calcified (1077)

Patient Problems Aortic Valve Stenosis (1717); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

A complete manufacturing and material records review for the perceval valve (model pvs25, sn (b)(4)) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the information available on the database, there is no indication of valve re-intervention.As such, since the device is not available for return, no further investigation is possible at this time.Based on the information available, the root cause cannot be definitively stated.It is possible that the patient's risk factors (diabetes; obesity) contributed to the reported structural valve deterioration.However, since no device inspection could be performed, this cannot be ultimately confirmed.Structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.The manufacturer is following up to gather additional information on this event and will provide a follow-up report if new information will be received.Device not explanted.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2014 a patient received a perceval pvs25 in aortic position.Good device functionality is recorded at discharge and in the yearly follow-up visits up to (b)(6) 2017.The manufacturer was informed on the following adverse event, which occurred on (b)(6) 2018: structural valve deterioration described as leaflet stiffening (calcified) and leading to stenosis.The patient is asymptomatic as a result of the reported event and no indication of a re-intervention is present on the database.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2014 a patient received a perceval pvs25 in aortic position.Good device functionality is recorded at discharge and in the yearly follow-up visits up to (b)(6) 2017.The manufacturer was informed on the following adverse event, which occurred on (b)(6) 2018: structural valve deterioration described as leaflet stiffening (calcified) and leading to stenosis.The patient is asymptomatic as a result of the reported event and no indication of a re-intervention is present on the database.Per additional information received, the stenosis detected in (b)(6) 2018 was defined as "moderate" although the evolution compared to the previous year was pejorative.In (b)(6) 2019, the patient was monitored for cardiac decompensation with multifactorial origin.The patient is euvolemic and well compensated clinically.

Manufacturer Narrative

The manufacturer received additional information and provided an updated event description in b5.The remainder of the information and root cause analysis previously submitted remains unchanged.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10006064
• MDR Text Key: 191914731
• Report Number: 3005687633-2020-00120
• 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
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 66