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

Model Number	PVS27
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Based on the information received, on (b)(6) 2022, a perceval sutureless aortic hear valve pvs27 was implanted in the patient through median sternotomy.The concomitant procedure was cabg.Reportedly, on (b)(6) 2022, third degree av block started and on (b)(6) 2022, a temporary pacemaker was implanted.Based on the update received from the site, on (b)(6) 2022, a permanent pacemaker was implanted in the patient, and patient was discharged from the hospital.The outcome was reported as recovered/resolved.Patient had a history of coronary artery disease, angina (stable ccs class ii), systemic hypertension, and diabetes mellitus type ii.Patient also underwent percutaneous coronary intervention (stenting) in 2011.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve and stent, model #icv1211, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1211) perceval heart valve at the time of manufacture and release.Based on the available information, it is not possible to draw a definitive root cause on the reported event.However, based on the document review performed, no manufacturing deficiencies were identified.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.Device remains implanted.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 16321367
• Report Number: 3004478276-2023-00112
• Device Sequence Number: 20794463
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)230201
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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: 02/01/2023
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• 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: 01/10/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Male