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	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is following up with the site to retrieve further information regarding this event and the device involved.A follow up report will be provided upon receipt of any further information.H3 other text : device remains implanted.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023 a patient was implanted with a perceval size xl valve.There was concomitant cabg surgery performed (1 vessel).The patient was in sinus rhythm post-operatively but was put under temporary pacemaker as per hospital protocol.Corcym representative was informed on (b)(6) 2023 that the patient was unable to get off temporary pacing and was scheduled for a permanent pacemaker implant.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023 a patient was implanted with a perceval size xl valve due to stenosis of the native valve leaflets.There was concomitant cabg surgery performed (1 vessel).The patient was in sinus rhythm post-operatively but was put under temporary pacemaker as per hospital protocol.Corcym representative was informed on (b)(6) 2023 that the patient was unable to get off temporary pacing and was scheduled for a permanent pacemaker implant.As per additional iformation received, permanent pacemaker was implanted on (b)(6) 2023 with no complications.As per medical judgement received, it's possible that the patient sinus rhythm will recover, hence the patient will be monitored by the cardiologists accordingly.The site didn't identify any procedural factors that may have contributed to the event.The patient's medical history and relevant risk factors, including a history of conduction disorders, are unknown and no information was shared with the manufacturer on patient's medication.It was reported that after implant the valve showed good flow, no regurgitation and improved lower mean and peak pressure gradients.No device malfunction is reported by the surgeon.
Additional Manufacturer Narrative
Updated fields: a2, b2, b5, g3, h2, h6, h10.The manufacturing and material records for the perceval heart valve and stent, model #icv1211, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by manufacture¿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.Since the device remains implanted in the patient, no further investigation can be performed.No device malfunction has been reported by the site though and there is no evidence that the device didn't meet the specifications.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.

• 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: 16924964
• Report Number: 3004478276-2023-00146
• Device Sequence Number: 6805354
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)260826
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 08/26/2026
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male