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

Model Number PVS23

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2022

Event Type  Injury  

Event Description

The manufacturer was informed that the patient underwent percival sutureless aortic valve pvs23 implantation on (b)(6) 2022 due to severe aortic stenosis.After implanting, immediate echo was performed with good hemodynamic result.Before transfer, patient's clinical status was worsening.As such, patient's chest was re-opened, and the inspection found that perceval valve was dislocated into aortic arch close to lt.Subclavian artery.As such, avalus 23mm was implanted in the patient.Patient's hemodynamic improved and peripheral pulses were detectable.Thus, surgeon decided to leave perceval in place as patient¿s status seemed stable at that moment.Reportedly, no sign of peripheral vascular obstruction observed.Aortic arterial cannula was reported as 22 fr.

Manufacturer Narrative

Device not explanted (tavr).

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and the stent, model #icv1209, 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 #icv1209) perceval heart valve at the time of manufacture and release.The manufacturer is following up with the site to retrieve further information regarding the event and the device involved.A follow up report will be provided upon receipt of any further information.

• 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: 15955644
• MDR Text Key: 305234957
• Report Number: 3004478276-2022-00212
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)240911
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 74 KG