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

Model Number PVS23

Device Problems Leak/Splash (1354); Incomplete Coaptation (2507)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/14/2022

Event Type  Injury  

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 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.Further investigation is ongoing.

Event Description

On (b)(6) 2022, a patient was treated with an aortic valve replacement and cabg (right coronary graft) procedure.A perceval valve pvs23 was selected for the avr.Following the seating and opening of the prothesis into the aortic annulus, it was noticed that at the time of balloon dilation the blue marker ring of the balloon was positioned too high i.E.Instead of being level with the valve leaflets, the blue marker ring was approximately 1 cm higher.The balloon was immediately deflated and moved into the correct position.The valve appeared to be intact; therefore, we performed another dilation with the correct balloon position.The valve still appeared intact and closure of the aortotomy commenced.Upon control, intraoperative trans esophageal echocardiography valvular insufficiency was detected, with correct valve position and no paravalvular leak.The grade of aortic insufficiency was ii; therefore, we decided to rearrest and change the valve prothesis.A new perceval pvs23 valve was implanted.The intraoperative control tee showed good valve position and function, with noted pvl at the septal site.No device malfunction was identified.The second cross clamp time was 20min and the second pump run 35 min.The patient remained stable.The echo performed on 28 feb 2022 showed good left ventricular function, no wall motion abnormality.Aortic valve gradient 28/15 mmhg, mild grade pvl.

Event Description

On (b)(6) 2022, a patient was treated with an aortic valve replacement and cabg (right coronary graft) procedure.A perceval valve pvs23 was selected for the avr.Following the seating and opening of the prothesis into the aortic annulus, it was noticed that at the time of balloon dilation the blue marker ring of the balloon was positioned too high i.E.Instead of being level with the valve leaflets, the blue marker ring was approximately 1 cm higher.The balloon was immediately deflated and moved into the correct position.The valve appeared to be intact; therefore, another dilation with the correct balloon position was performed.The valve still appeared intact and closure of the aortotomy commenced.Upon control, intraoperative trans esophageal echocardiography valvular insufficiency was detected, with correct valve position and no paravalvular leak.The grade of aortic insufficiency was ii; therefore, the heart was re-arrested, the perceval valve prothesis was explanted and replaced with a new perceval pvs23 valve.The intraoperative control tee showed good valve position and function, with noted pvl at the septal site.No device malfunction was identified.The second cross clamp time was 20min and the second pump run 35 min.The patient remained stable.The echo performed on (b)(6) 2022 showed good left ventricular function, no wall motion abnormality.Aortic valve gradient 28/15 mmhg, mild grade pvl.

Manufacturer Narrative

The device involved in the reported event was returned to the manufacturer for investigation.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications.The height of each leaflet has been verified, resulting in conformity.In order to allow an exhaustive evaluation of the functional behavior, the returned prosthesis underwent hydrodynamic testing in simulated physiological conditions.The results showed that the effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 2.34 cm2, well above the iso 5840 minimum requirement 1.25 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 7.5% and it is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in both normotensive and hypotensive conditions.A review of the steady flow test images performed at the time of manufacture and release of the valve pvs23 sn b09275 was performed.The results demonstrated the acceptable opened and closed leaflet performance of the perceval pvs23 sn# b09275.No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection as defined in the principal device function test at the time of release.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because no regurgitation and no open/close anomalies were observed during the functional test under hydrodynamic testing conditions.Furthermore, no deficiencies were identified during the reviews of the production records and steady flow test inspection.Based on the manufacturer¿s clinical experience, possible root causes for events of intra-operative central leak could be related to procedural factors like device mis-sizing or device mispositioning.However, this can not be ultimately confirmed based on the available information provided.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity.

• 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: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13863303
• MDR Text Key: 289359866
• Report Number: 3004478276-2022-00137
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)250714
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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: 75 YR