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

Model Number PVS25

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/31/2022

Event Type  Injury  

Event Description

The manufacturer was informed that on (b)(6) 2022, a perceval sutureless aortic heart valve, pvs25 was attempted to be implanted.The valve would not close and there was a major aortic insufficiency, as reported.Blood was going back into heart after clamp was removed.Once the cross clamp was removed and they went back ¿on pump¿ at 5 l/m the lt ventricle began to fill with blood to the point that it looked like it would burst.It was mentioned that the valve seemed to be in good position from the tee and upon visual inspection, but it appeared to be totally incompetent once the cross clamp was removed.The aortotomy was opened to recheck the perceval valve it looked to be in good position and alignment.The leaflets did not coapt, but it was possible to pull them together.Thus, t was believed at that time that once the system is under pressure that they would coapt appropriately.So, the aortotomy was closed to try one more time.This brought the same result of the ventricle filling with blood and the valve appearing to be totally incompetent.As such, the valve was explanted and a medtronic mosaic 23mm valve was implanted instead.Reportedly, the native valve was bicuspid with severe ai, and hypertrophied septum.The concomitant procedures performed included: vein harvesting, the atrial appendage ligation, the distals for bypass, the avr (perceval then mosaic), then the proximal for bypass, and cabg x 3.Based on the information received, no abnormal geometry in the patient anatomy was noted.Approximately less than 30 minutes was added to cross-clamp time and bypass time.Patient remained stable for the most part of the procedure, however there was about a 15-20 min period of time that the team was scrambling.During this time the pump was slowed, the patient was took off of the cross clamp and went back on pump at 5l/min.At this point patient had loss of pressures.There was too much blood in heart (entire rt ventricle distended), not returning to profusion pump.As such, they gave more plegia (800) to the patient as well as potassium.It was reported that patient was doing well after the surgery.However, on 23 sep 2022, the manufacturer received a copy of the site's mw report to fda (uf/importer report #: (b)(4)) indicating the patient was initially admitted with nstemi and aortic stenosis.Reportedly, patient required multiple blood products during the surgery.It was also mentioned that patient has died in (b)(6) 2022, exact day was not indicated.Based on the additional information received, patient did not survive through the weekend after this surgery.Based on the information available, the surgery was completed without any issue and patient was doing well after the surgery but the patient suddenly passed away due to unknown cause and on unknown date after the surgery was completed and medtronic mosaic 23mm valve was implanted in the patient.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1210, 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 #icv1210) perceval heart valve at the time of manufacture and release.The steady flow test was also performed.The images demonstrate the acceptable opened and closed leaflet performance of the perceval pvs25 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 dedicated procedure at the time of release.

Manufacturer Narrative

Valve was returned to the manufacturer.After decontamination, the valve was visually inspected without highlighting elements of non-conformity.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 2.72 cm2, well above the iso 5840 minimum requirement 1.45 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 6.1 % and it is below the requirement of iso 5840 (rf% < 15%) for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in both normotensive and hypotensive conditions regarding the total and full coaptation of the leaflets.Although a leaflet (i.E.The leaflet #3) appears with an anomalous shape in the open configuration, it is important to highlight that this configuration appears only in hypotensive conditions and not in normotensive ones and, above all, it is not visible in the steady flow test, therefore it is reasonable to state that it may be due to some small undetected deformations that occurred during implantation / explantation or to possible non-optimal storage conditions before returning the prosthesis to corcym.However, the observed feature is totally unrelated to the coaptation problem that was reported by the customer, which, on the contrary, is probably due to the patient's peculiar anatomy.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, from the document review performed, no manufacturing deficiencies were identified.The root cause of the reported event can be traced to the patient's peculiar anatomy (i.E., bicuspid valve).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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15505212
• MDR Text Key: 300899261
• Report Number: 3004478276-2022-00189
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)230320
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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