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

Model Number PVS25

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Thrombocytopenia (4431)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Remained implanted.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 305584569
• Report Number: 3004478276-2022-00214
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)250113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male