MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVF-S

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/06/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : still implanted (under monitoring).

Event Description

On (b)(6) 2023, a perceval valve size s was implanted in a patient through full sternotomy.This was a redo avr to replace the degenerated 19mm trifecta valve which was implanted in 2017.Post implantation echo showed no pvl.Procedure was completed, patient was sent to icu and was discharged later on.As reported, patient was presented again after 20 days (b)(6) with chest pain and unable to do any physical activities.The new echo revealed moderate pvl.After discussion, it was decided that the repositioning of the valve is not a feasible option as the patient is very frail and will not be able to take stress from cpb.Based on the further information received, this was an isolated procedure, and the valve was positioned supra-annular.Echo shows good functionality of the valve.No positioning difficulty were noted.Reportedly, a small tear noticed after explanting the degenerated trifecta valve which was repaired before implanting the perceval valve.The patient has been closely monitored and has been advised for amplatzer plug to be implanted in january for pvl management.

Event Description

On (b)(6) 2023, a perceval plus valve size s was implanted in a patient through full sternotomy.This was a redo avr to replace the degenerated 19mm trifecta valve which was implanted in 2017.Post implantation echo showed no pvl.Procedure was completed, patient was sent to icu and was discharged later on.As reported, patient was presented again after 20 days (~ (b)(6)) with chest pain and unable to do any physical activities.The new echo revealed moderate pvl with good valve functionality.After discussion, it was decided that the repositioning of the valve was not a feasible option as the patient is very frail and would not be able to take stress from cpb.Based on the further information received, no concomitant procedures were performed at the time of perceval valve implant and the valve was positioned supra-annular.No positioning difficulties were noted.Reportedly, a small tear was noticed after explanting the degenerated trifecta valve which was repaired before implanting the perceval prosthesis.The patient has been closely monitored and has been treated with an amplatzer plug implant in (b)(6) 2024 to correct the pvl.Reportedly, the procedure has been completed with good results and the patient is doing fine with trivial leak and good hemodynamics.

Manufacturer Narrative

The manufacturer is further investigating to assess the possible root cause of the reported event.A follow up report will be submitted at the completion of the investigation or upon receipt of any additional information.

Manufacturer Narrative

A complete manufacturing and material records review for the sutureless valve pvf-s sn: (b)(6) involved in the reported event 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 manufacturer is following up with the site to retrieve additional information on the event and the device involved.A follow up report will be provided upon receipt of further information.H3 other text: still implanted (under monitoring).

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18403078
• MDR Text Key: 331482665
• Report Number: 3005687633-2023-00131
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2024

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 Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/19/2024; 03/04/2024
• Supplement Dates FDA Received: 02/16/2024; 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2023
• 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): Other
• Patient Age: 78 YR
• Patient Sex: Female