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 Codes	Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
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 percival valve pvs21 was implanted.On (b)(6) 2021, the patient was hospitalized for left cardiac decompensation with discovery of degeneration of the percival 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.Based on additional information received, the preoperative echo (performed in (b)(6) 2016) showed presence of calcifications in the native aortic valve (mean gradient = 80mhg).The postoperative ultrasound showed preserved lvef, moderate lv hypertrophy (detected also pre-operatively) and a mean transaortic gradient of 17mmhg.The echo performed on (b)(6) 2021 before the reoperation confirmed the degeneration of the perceval valve prosthesis resulting in aortic stenosis (mean gradient 69mmhg) and moderate to medium regurgitation.
Additional Manufacturer Narrative
Fields updated: 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.Since the device was not explanted, no further investigation is possible at this time.Based on the information available, it is not possible to establish a definitive root cause for the reported event.As reported in the scientific literature, structural valve deterioration is the major cause of failure of bioprosthetic heart valves.It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this percival valve.However, little clinical history was provided for this patient, and this cannot be definitively stated.Ultimately, since no device investigation is possible, the root cause cannot be established at this time.It should be noted that structural valve deterioration is listed as a possible adverse event in the percival valve ifu.The event is, therefore, a known inherent risk of the device.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13125063
• Report Number: 3005687633-2021-00170
• Device Sequence Number: 4465086
• Product Code: LWR
• UDI-Device Identifier: 08022057014696
• UDI-Public: (01)08022057014696(240)ICV1208(17)200314
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG