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

Model Number PVF-M

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/23/2022

Event Type  Injury  

Event Description

The manufacturer was informed that on 23 aug 2022, a perceval plus sutureless aortic heart valve size m valve was implanted.After closing the aorta, post-implantation tee showed only central jet and no paravalvular leakage, so the aorta was clamped again and the implanted valve was inspected and there was a kinking in the lcc region.As such, the valve was explanted carefully and cramped again twice and it showed a sort of valve deformity or asymmetry.As reported, they had the feeling that one cusp was a bit bigger than the other two cusps.Ultimately, it was decided not to implant the valve and a new perceval plus valve size m was implanted using the same accessory kit.The new valve was implanted without any problems.The post-implantation tee showed perfect result.

Manufacturer Narrative

The valve was returned to the manufacturer.No pre-existing defects were identified.The hydrodynamic testing was conducted on the pvf-m.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and and mean backpressure of about 100 mmhg is 2.47 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 3.4 % 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.Although a visual inspection, conducted on the ¿relaxed¿ valve, can give the feeling of deformity or asymmetries in the leaflets and / or cusps, these are not to be considered an exhaustive aspect to judge the potential behavior of the valve once implanted.The manufacturer is retrieving and reviewing the production record of the valve, once completed, a follow up report will be provided.

Event Description

The manufacturer was informed that on (b)(6) 2022, a perceval plus sutureless aortic heart valve size m valve was implanted through mics (j shape sternotomy).After closing the aorta, post-implantation tee showed only central jet and no paravalvular leakage, so the aorta was clamped again, and the implanted valve was inspected and there was a kinking in the lcc region.As such, the valve was explanted carefully and cramped again twice, and it showed a sort of valve deformity or asymmetry.As reported, they had the feeling that one cusp was a bit bigger than the other two cusps.Ultimately, it was decided not to implant the valve and a new perceval plus valve size m was implanted using the same accessory kit.The new valve was implanted without performing any further decalcification and without any problems and the post-implantation tee showed perfect result.Based on the information received this was an isolated avr procedure, and there was no concomitant procedure.Patient's native valve had aortic stenosis iii° + aortic regurgitation i°.There was no device malfunction and echo data is not available.Reportedly, patient's annulus was severely calcified due to bicuspid form of the valve.Cross-clamp time added was 36 minutes, and bypass time added was around 45 minutes.Patient was stable through the procedure and had a good outcome after the implantation of the second valve.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-m, 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 #pvf-m) perceval plus heart valve at the time of manufacture and release.Based on the investigation performed, the reported event cannot be explained by any factor intrinsic to the returned device, as no malfunctions nor elements of non-conformity were detected.Furthermore, from the document review performed, no manufacturing deficiencies were identified.This was also confirmed by the information received (i.E., there was no malfunction with the device).The root cause of the reported event can possibly be traced to the patient's peculiar anatomy (i.E., severely calcified annulus and bicuspid valve).

• Brand Name: PERCEVAL PLUS 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 V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 15450808
• MDR Text Key: 300216009
• Report Number: 3004478276-2022-00186
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)250522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 66 KG