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

Model Number PVS23

Device Problem Difficult to Open or Close (2921)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, it was suspected that a valve thrombus have generated on a perceval valve that was implanted on (b)(6) 2021.This event was detected at the follow up performed on the patient.The patient is asymptomatic and was discharged from the hospital.There is no plan for re-intervention on the patient who is planned to follow up in 3 months.No further information regarding the device relationship was provided from the hospital.It is unknown if the patient has any coagulation disorders.On pod12, the tee showed that the ncc leaflet movement was restricted.Regarding the anticoagulation therapy, until pod12 the patient was receiving only warfarin, and the inr was controlled from 1.5 to 2.0.After pod12, warfarin and bayaspirin were administered, and inr was controlled more than 2.At the ct scan performed on pod7, halt was found at the base of the ncc (around the annulus).

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at corcym (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Based on the information available, it is not possible to draw a definitive conclusion on the reported event.However, from the document review performed, no manufacturing deficits were identified.The manufacturer attempted to retrieve additional information on the clinical history and baseline conditions of the patient, as well as a medical judgment on the event, but no further information was provided.Should further information become available on this event, a follow up report will be provided.Device remains implanted.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• MDR Report Key: 11988061
• MDR Text Key: 281167256
• Report Number: 3004478276-2021-00170
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220702
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 06/11/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 39