MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVS25
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
Manufacturer was informed that on (b)(6) 2024, a perceval valve pvs25 was implanted in a patient.Reportedly, av block was noted when the patient left the operating room but was stopped at icu on (b)(6) 2024.However, on (b)(6) 2024, av block was noted again, and temporal pacing was started.On (b)(6) 2024, av block was noted again.As such, pacemaker was implanted.No further information is available at this time.
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.Since limited information is available, the definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies were noted.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval ifu.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6.Since limited information is available, the definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies were noted.Based on the further information received, low positioning of the valve at n/r commissure during implant is possible.As such, cause of the reported event can possibly be related to the mispositioning of the device (use error).Should further information be received in the future, a follow up report will be provided.
Event or Problem Description
Manufacturer was informed that on (b)(6) 2024 a perceval valve pvs25 was implanted in a patient.Reportedly, av block was noted when the patient left the operating room but was stopped at icu on (b)(6) 2024.However, on (b)(6) 2024, av block was noted again, and temporal pacing was started.On (b)(6) 2024, av block was noted again.As such, pacemaker was implanted.Based on the further information received, outcome was good, and no device malfunction was noted.Reportedly, low positioning of the valve at n/r commissure during implant is possible.No further information is available.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 19076060
• Report Number: 3004478276-2024-00127
• Device Sequence Number: 15178637
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)260301
• 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: 2024
• 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,Followup
• Report Date (Section B): 06/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 06/10/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/10/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Male