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

Model Number	PVS25
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombocytopenia (4431)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remained implanted.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2022, a perceval sutureless aortic heart valve pvs25 was implanted.Reportedly, the platelet count was15,000 as of (b)(6) 2022, which required a blood transfusion.As reported, patient is recovering.No further information is provided at this time.
Additional Manufacturer Narrative
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 satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.Based on the medical judgment received, the cause of the event might be related to the patient factors (i.E., dialysis).Furthermore, per the document review performed, no manufacturing deficiencies were identified with the perceval valve involved in the event.As such, the cause of the event was possibly related to patient condition.Should further information be received in the future, a follow up report will be provided.
Event or Problem Description
The manufacturer was informed that on 15 november 2022, a perceval sutureless aortic heart valve pvs25 was implanted.Reportedly, the platelet count was15,000 as of 17 nov 2022, which required a blood transfusion.As reported, patient is recovering.Based on the further information received, patient got well.Patient is a dialysis patient and based on the medical judgment received, the event might be related to the dialysis (patient factor).

• 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: 15992824
• Report Number: 3004478276-2022-00214
• Device Sequence Number: 6103603
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)250113
• 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: 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,Followup
• Report Date (Section B): 02/10/2023

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: 01/13/2025
• Device Model Number: PVS25
• Device Catalogue Number: ICV12010
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male