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

Model Number	PVS21
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, a perceval valve pvs21 was implanted.On (b)(6) 2021, the patient was hospitalized for left cardiac decompensation with discovery of degeneration of the perceval bioprosthesis.On (b)(6) 2021, the cardiac ultrasound showed degeneration of the perceval valve.A tavi was scheduled on (b)(6) 2021 to treat the patient.
Event or Problem Description
On (b)(6) 2016, a perceval valve pvs21 was implanted.On (b)(6) 2021, the patient was hospitalized for left cardiac decompensation with discovery of degeneration of the perceval bioprosthesis.On (b)(6) 2021, the cardiac ultrasound showed degeneration of the perceval valve.A tavi was scheduled on (b)(6) 2021 to treat the patient.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 13125048
• Report Number: 3019892983-2021-01058
• Device Sequence Number: 14569037
• Product Code: LWR
• UDI-Device Identifier: 08022057014696
• UDI-Public: (01)08022057014696(240)ICV1208(17)200314
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2021
• Report Date (Section F): 12/02/2021

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: 03/14/2020
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2021
• 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: Required Intervention
• Patient Sex: Unknown