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

Model Number PVS23

Device Problems Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

The manufacturer was informed that on (b)(6) 2023 an attempt to implant a perceval s aortic sutureless valve size medium was made.Reportedly, the decision to implant a perceval valve was made because of the small patient's annulus (21 mm as per tee assessment).As per indication from the sizing procedure, a valve size m was selected and implanted.During reperfusion, an insufficiency was found which required to stop the heart again (2nd cross-clamp).The valve was inspected and it seemed it had not expanded correctly on the right coronal side; hence the decision was made to re-implant the valve.In the renewed reperfusion, the tee showed again a valvular insufficiency, so it was deciced to remove the perceval valve and implant a bioprosthesis from a different manufacturer (21 mm intuity, edwards lifesciences) (3rd cross-clamp).Total surgery time was 3 hrs 50 mins; additional cross clamp time was 1 hr 47 mins and by-pass time was 2 hrs 39 mins.As reported, further inspection of the explanted perceval valve showed that one leaflet was appearing significantly stiffer than the others.The manufacturer was informed that the patient didn't experience any complication as a consequence of this event and the patient was transferred to the intensive care unit under stable cardiovascular conditions with very low doses of catecholamines.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h3, h6, h10.Corrected fields: 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 a manufacture¿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 returned valve was received in suboptimal conditions without storage solution, even if still wet.The valve was visually inspected without highlighting elements of non-conformity according to the specifications, except for a slightly reduced elasticity found on the second leaflet.A hydrodynamic testing has been conducted on the returned prosthesis.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg was 2.56 cm2 , above the iso 5840 minimum requirement of 1.25 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction was 3.0 % which is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent size.No anomalies were observed in leaflets coaptation during the open/close cycle in normotensive conditions.In hypotensive conditions a slight central leakage was detected during the diastolic phase.It cannot be excluded that the observed slight central leakage is correlated to the reported behaviour observed during the implant procedure neither that it could be due to the alteration in mechanical properties of the pericardium caused by the not correct storage conditions.In any case this was not found in normal operating conditions (normotensive conditions).Based on the performed analysis, the reported event cannot be explained by any factor intrinsic to the involved device.Review of the data filed in the device history record of the returned perceval heart valve sn (b)(6) confirmed that the valve satisfied all material, dimensional, and performance standards required for a perceval heart valve prosthesis pvs 23/m at the time of manufacture and release, including visual inspection and steady flow test.Furthermore, the claimed issue was not observed during the investigation carried out (i.E.Hydrodynamic test) despite the valve was returned in suboptimal conditions.Reportedly, patient's native annulus was small (21 mm as per tee assessment) and a 21 mm intuity valve from edwards lifesciences was ultimately implanted.As such, it cannot be excluded that the reported issue might have been caused by an oversizing of the valve.A second attempt to reimplant the same valve has been made though; it should be noted that this second attempt was made off label since, according to ifus, a removed perceval plus prosthesis must not be reimplanted, because its integrity is no longer ensured.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 17114380
• MDR Text Key: 317864331
• Report Number: 3004478276-2023-00155
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)260420
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 65 KG