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

Model Number	PVF-L
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombocytopenia (4431)
Date of Event	10/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve size l was implanted in the patient on (b)(6) 2023.Concomitant procedure was cabg which was performed before implant.Based on information received, patient got thrombocytopenia on (b)(6) 2023.As such, platelets transfusion was performed.As reported, the patient's clinical history included cad, systemic hypertension, diabetes mellitus type ii - insulin dependent, dyslipidemia, and stroke.Patient was nyha class ii.Based on the information reported, aspirin was stopped before implant, platelet count was reported as (152 109 /l) at pre-op, and (72 109 /l) at discharge.Patient was discharged on (b)(6) 2023.Based on the tee and tte, no functionality issue with the valve was noted after procedure, and no regurgitation was noted at the time of discharge.Mean gradient was11 mmhg.
Additional Manufacturer Narrative
H3 other text : still implanted.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model # pvf-l, 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 # pvf-l) perceval plus heart valve at the time of manufacture and release.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.

• Brand Name: PERCEVAL PLUS 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: 18203399
• Report Number: 3004478276-2023-00204
• Device Sequence Number: 6414708
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)270611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011/S013
• 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
• Report Date (Section B): 01/23/2024

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 Model Number: PVF-L
• Device Catalogue Number: PVF-L
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2023
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 62 KG