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

Model Number	PVS25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombocytopenia (4431)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event: a perceval valve size 25 was implanted in a patient on (b)(6) 2023.On the next day after the surgery, the thrombocyte level got down to 60000 and decreased to 19000 two days after surgery.Blood transfusion was started, and the level was increased up to 30000 and remained the same after that.Reportedly, the patient has not been recovered yet.No further information is available at this time.
Additional Manufacturer Narrative
H3 other text : device remains implanted.
Additional Manufacturer Narrative
Based on the information available, it is not possible to draw a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified with the perceval valve involved in the event.Thrombocytopenia (tcp) in cardiac surgery is a very well-known phenomenon.The etiology is multi-factorial due to multiple factors including hemodilution, blood loss with volume repletion with platelet-poor fluids, platelet activation, consumption and destruction due to contact with foreign surfaces.Tcp following aortic valve replacement (avr) is also a common phenomenon.Patient factors and prolonged extracorporeal circulation all being recognized predictors of tcp following cardiac surgery.
Event or Problem Description
The manufacturer was informed of the following event: a perceval valve size 25 was implanted in a patient on (b)(6) 2023.On the next day after the surgery, the thrombocyte level got down to 60000 and decreased to 19000 two days after surgery.Blood transfusion was started, and the level was increased up to 30000 and remained the same after that.Reportedly, the patient has not been recovered yet.Based on the additional information received, patient was discharged from the hospital and is under follow-up.As reported, platelets transfusion was performed 2 times.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6.The manufacturing and material records for the perceval heart valve, model # icv1210, s/n # (b)(6) as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1210 perceval heart valve at the time of manufacture and release.The manufacturer is following up to retrieve further information regarding this case and the device involved.A follow up report will be provided upon receipt of any further information.

• 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: 17978699
• Report Number: 3004478276-2023-00186
• Device Sequence Number: 19446407
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)241020
• 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
• 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): 12/20/2023

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: 10/20/2024
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 11/24/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/24/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: 78 YR
• Patient Sex: Female