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

Model Number PVS21

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(4), 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 #icv1208) perceval heart valve at the time of manufacture and release.Review of the steady flow test demonstrate the acceptable opened and closed leaflet performance of the perceval pvs21 sn# (b)(4).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in the dedicated procedure at the time of release.The device is returned to the manufacturer and the investigation is on going.The follow up will be provided upon the completion of the investigation.

Event Description

The manufacturer was informed of the following event: pvs21 was implanted with a midline incision on (b)(6) 2022.The concomitant procedure was mitral valvuloplasty.During the surgery, the position of the device was confirmed and the balloon was expanded.After ballooning, the position of the device was confirmed one more time.The incision in the aorta appeared to be low, but the incision was ligated and the blood flow resumed.Initially, pvl was observed around ncc side and lcc side.When the blood flow volume was added, prominent pvl and central leakage from the entire lcc side were observed.In the echo, it looked similar to trans valvular leakage, so a decision was made to redo the implantation.When the aorta was incised again and the device checked visually, the lcc side was popped up.The device was removed and another perceval valve was implanted.The position of the new valve was checked and had no problem.Echo showed neither pvl nor central leak.After removal, it was confirmed that there was no problem with the shape and functionality of the explanted device.Extracorporeal circulation time was extended by approximately 45minutes to replace the perceval.The medical judgment received regarding this event is as follow: ''it is considered that the cause of this event was the fact that the lcc side popped up during process from ballooning after deployment to ligation of the aortic incision.The higher position of the lcc side may have caused a regurgitation that looked like a trans leakage.''.

Manufacturer Narrative

The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications.The high of each leaflet has been verified by means the specific tool resulting in conformity.The hydrodynamic testing conducted on the pvs 21/s was performed.The effective orifice area (eoa) of cardiac output and mean aortic pressure were measured and were well above the minimum requirement.The regurgitant fraction was also below the requirement for a prosthesis of equivalent tad.R hydrodynamic test was also performed.No anomalies were observed during the open/close cycle in both normotensive and hypotensive conditions.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.No problems were detected in the returned device.Based on the manufacturer's experience with similar cases, intraoperative events of perivalvular leak may be caused by a device mis-sizing, device malpositioning at the time of the event, or manipulation of the heart.Given that a new perceval valve of the same size was ultimately implanted, the mis-sizing can be reasonably excluded as root cause of this event.As reported, "when the aorta was incised again and visually checked the device, the lcc side was popped up." it is possible that the valve may have not been correctly positioned at the time of implant, thus leading to the tilting and subsequent perivalvular leak.However, given the information provided (device position was visually confirmed), the exact root cause of the reported event cannot be ultimately confirmed at this time.

Manufacturer Narrative

Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.No problems were detected in the returned device.Based on the manufacturer's experience with similar cases, intraoperative events of perivalvular leak may be caused by a device mis-sizing, device malpositioning at the time of the event, or manipulation of the heart.Given that a new perceval valve of the same size was ultimately implanted, the mis-sizing can be reasonably excluded as root cause of this event.As reported, "when the aorta was incised again and visually checked the device, the lcc side was popped up." it is possible that the valve may have not been correctly positioned at the time of implant, thus leading to the tilting and subsequent perivalvular leak.However, given the information provided (device position was visually confirmed), this cannot be ultimately confirmed.Based on the medical judgement received, the cause of the reported event was attributed to the surgical technique.As such, cause of the event was procedure related.Should further information be received in the future, the manufacturer will provide a follow up report.

Event Description

The manufacturer was informed of the following event: pvs21 was implanted with a midline incision on (b)(4) 2022.The concomitant procedure was mitral valvuloplasty.During the surgery, the position of the device was confirmed and the balloon was expanded.After ballooning, the position of the device was confirmed one more time.The incision in the aorta appeared to be low, but the incision was ligated and the blood flow resumed.Initially, pvl was observed around ncc side and lcc side.When the blood flow volume was added, prominent pvl and central leakage from the entire lcc side were observed.In the echo, it looked similar to trans valvular leakage, so a decision was made to redo the implantation.When the aorta was incised again and the device checked visually, the lcc side was popped up.The device was removed and another perceval valve was implanted.The position of the new valve was checked and had no problem.Echo showed neither pvl nor central leak.After removal, it was confirmed that there was no problem with the shape and functionality of the explanted device.Extracorporeal circulation time was extended by approximately 45minutes to replace the perceval.The medical judgment received regarding this event is as follow: ''it is considered that the cause of this event was the fact that the lcc side popped up during process from ballooning after deployment to ligation of the aortic incision.The higher position of the lcc side may have caused a regurgitation that looked like a trans leakage.'' based on the additional information received, surgeon mentioned that the root cause of the reported event was attributed to the surgical technique.Reportedly, there was no impact on the patient and patient has been discharged.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• 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: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 14086967
• MDR Text Key: 289098600
• Report Number: 3004478276-2022-00143
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)241020
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 70 KG