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

Model Number PVS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Weight Changes (2607); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/20/2022

Event Type  Injury  

Event Description

The manufacturer was informed that on (b)(6) 2022, a perceval valve size s23 was implanted in the patient.On (b)(6) 2022, the patient's condition deteriorated.Anorexia, weight loss, and aortic regurgitation were observed.There were also signs of heart failure.On (b)(6) 2022, tee confirmed the aortic regurgitation.The valve was eventually explanted on (b)(6) 2022.As per echo review, the device was dislodged.Reportedly, after the explant of the valve it was noted that part of cuff was not flat and was transformed but it was unclear when the product has been deformed.Based on the information received, perioperative and postoperative ct was investigated, and no leak was found.Furthermore, the concomitant procedure was avr+ cabg full sternotomy.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6.The manufacturing and material records for the perceval heart valve and 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 device has not yet been returned to the manufacturer.The manufacturer will submit a follow up report upon receipt of the device.

Manufacturer Narrative

The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.During the simulation of the valve deployment, in silicon aortic roots #21 and #23, no problems were encountered during the ballooning phase.The sealing at the annulus level was guaranteed, and the valve remained fixed within the annulus.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks were observed during both the simulations, considering the static conditions of the test.The water level remained stable under the leaflets free edge.Based on the information available, the definitive root cause of the reported event cannot be established.However, from the performed analyses, it is possible to exclude any relationship between the device quality and the reported issue.Furthermore, based on the document review performed, no manufacturing deficiencies was noted.Should further information be received in the future, a follow up report will be provided.

• 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: 16028874
• MDR Text Key: 305980203
• Report Number: 3004478276-2022-00216
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS
• Device Catalogue Number: PVS23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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): Required Intervention