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

Model Number	PVS23
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a perceval valve size 23 was implanted in a patient.Since the valve was migrated post-surgery, it was explanted on (b)(6) 2023 and changed to competitor's valve.No further information is available at this time.
Event or Problem Description
On (b)(6) 2023, a perceval valve size 23 was implanted in a patient.Since the valve was migrated post-surgery, it was explanted on (b)(6) 2023 and changed to competitor's valve.Based on the further information received, no post-dilation ballooning was performed, no perivalvular or central leak was detected.Reportedly, no problem with the functionality of the valve was noted and there was no abnormal geometry in the patient's annulus.No further information is available.
Additional Manufacturer Narrative
The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The visual inspection confirmed the presence of pannus, in particular, on the sinusoidal structures between the posts #1 and #2 and around the sealing collar.The manufacturer is retrieving and reviewing the device manufacturing records.A follow up report will be provided upon completion of this review.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve and stent, model # icv1209-jp, s/n #(b)(6), as they pertain to the reported event, were retrieved and reviewed by a manufacture¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209-jp) perceval heart valve at the time of manufacture and release.The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The visual inspection confirmed the presence of pannus, in particular, on the sinusoidal structures between the posts #1 and #2 and around the sealing collar.Based on the limited information available, the definitive root cause of the reported event cannot be established at this time.However, from the document review and analysis performed, no manufacturing deficiencies were noted.From the performed analyses on the device, the reported event cannot be explained by any factor intrinsic in the involved device.Should further information be received in the future, a follow up report will be provided.

• 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
• 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: 17741745
• Report Number: 3004478276-2023-00176
• Device Sequence Number: 5654427
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)260126
• 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: 2023
• Device Explanted Year: 2023
• 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): 11/14/2023

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: 01/26/2026
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 11/03/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/02/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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
• Patient Sex: Unknown