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

Model Number	PVS23
Medical Device Problem Codes	Collapse (1099); Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the perceval valve s model pvs23 was attempted to be implanted.According to the information received from the site, the patient had a sever calcification in the aortic valve with the small lumen of annulus, which made the decalcification process complicated.There were no collapsing or implantation issues during the procedure.Ballooning was standard and normal.The position of the valve looked correct by the visual check.Although the blood flow was good, echocardiogram indicated grade ii and iii paravalvular leak at the non-coronary part of the valve.By further investigation, a not completely unfolded valve in the non-coronary side was detected.The valve was removed and implanted back again.In the second attempt the ballooning took place with the pressure of 5atm for 30 seconds.The same unfolding issue in the same spot occurred.At the end, the decision of removing the valve has been made.The doctor enlarged the aortic root with the dacron-patch, resized the annulus and decided to implant the magna ease aortic valve 21mm.According to the information received the patient was stable during the surgery, and no adverse impact on the patient has been reported.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 13213246
• Report Number: 3019892983-2022-01002
• Device Sequence Number: 19208746
• Product Code: LWR
• UDI-Device Identifier: 08022057014702
• UDI-Public: (01)08022057014702(240)ICV1209(17)240213
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2022
• Report Date (Section F): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2024
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2021
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown