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

Model Number PVS25

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834)

Event Date 10/10/2016

Event Type  Injury  

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.Further investigation is ongoing.Device location not presently known.

Event Description

The manufacturer received information on this event through the sure avr registry.On (b)(6) 2013, a (b)(6) female patient received a percival pvs25 to replace the native stenotic aortic valve.The procedure was performed in mini-thoracotomy and no concomitant procedures were performed.On (b)(6) 2016, endocarditis is reported.The microorganism was identified to be enterococcus faecalis.About one month later, on (b)(6) 2016, a structural valve deterioration occurred.The leaflet appeared stiffened (calcified), which resulted in valve stenosis.The patient was symptomatic.On the same day, the patient underwent surgery to have the percival explanted due to endocarditis on the deteriorated device.The functionality of the percival prosthesis was observed trough echo at discharge and at the yearly follow up visit, with the following findings: on (b)(6) 2013, the mean gradient was 20mmhg and no central/perivalvular leaks were reported; on (b)(6) 2014, the mean gradient was 25mmhg and no central/perivalvular leaks were observed.

Event Description

The manufacturer received information on this event through the sure avr registry.On 28 aug 2013, a 72 years old female patient received a perceval pvs25 to replace the native stenotic aortic valve.The procedure was performed in mini-thoracotomy and no concomitant procedures were performed.On 10 oct 2016, endocarditis is reported.The microorganism was identified to be enterococcus faecalis.About one month later, on (b)(6) 2016, a structural valve deterioration occurred.The leaflet appeared stiffened (calcified), which resulted in valve stenosis.The patient was symptomatic.On the same day, the patient underwent surgery to have the perceval explanted due to endocarditis on the deteriorated device.The patient did not have fever before the explant and antibiotic were administered before the perceval explant.After the re-intervention, the patient was discharged at home, where she continued her care.The functionality of the perceval prosthesis was observed trough echo at discharge and at the yearly follow up visit, with the following findings: on 02 sep 2013, the mean gradient was 20mmhg and no central/perivalvular leaks were reported; on 15 jul 2014, the mean gradient was 25mmhg and no central/perivalvular leaks were observed.

Manufacturer Narrative

If enterococcus faecalis was present on our tissue valve before sterilization, it would be killed very easily by our liquid chemical sterilant.The sterilant contains a mixture of glutaraldehyde and alcohol, both of which are highly effective against this organism.We have validated this liquid chemical sterilization process with spore forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.Following routine sterilization, the valves are aseptically packaged in a solution that inhibits the growth of microorganisms with steam sterilized closures and jars.The packaging process occurs in vaporous hydrogen peroxide (vhp) decontaminated isolator; therefore, there is no risk of valve contamination post-sterilization.Each closure/jar containing the valve is integrity tested after packaging, thus ensuring a sealed barrier for the product to remain sterile during transport up until the closure/jar is opened.Given livanova's sterilization procedure and the delayed onset of the patient's endocarditis (3 years post-implant), it is not feasible that the enterococcus species detected in the patient's blood culture originated from the valve.However, since there is no information available on the prosthesis' functionality at the time of the event and no device analysis was possible, the root cause of the event cannot be determined at this time.

• 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: 8203851
• MDR Text Key: 131698347
• Report Number: 3005687633-2018-00247
• 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: 01/31/2019

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: 04/11/2016
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 76