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

Model Number	PVF-L
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a large perceval plus valve was supposed to be implanted.After the ballooning, it was noticed that the leaflets did not fully come together.While attempting to come off the heart lung bypass machine, a mild central leak was noted.Thus, went back off pump, the perceval plus valve was removed and inspiris size 25 was implanted instead.Based on the medical judgement received, the valve may have undersized initially.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model #pvf-l, 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 #pvf-l) perceval plus heart valve at the time of manufacture and release.The steady flow test review was also performed; images demonstrate the acceptable opened and closed leaflet performance of the perceval plus pvf-l 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.The manufacture is following up with customer to retrieve additional information.The manufacturer also received confirmation that the device is available for return; as such, further investigation will be performed upon device receipt and a follow up report will be provided.
Event or Problem Description
On 12 may 2022, a large perceval plus valve was supposed to be implanted.After the ballooning, it was noticed that the leaflets did not fully come together.While attempting to come off the heart lung bypass machine, a mild central leak was noted.Thus, went back off pump, the perceval plus valve was removed and inspiris size 25 was implanted instead.Based on the medical judgement received, the valve may have undersized initially.Based on the additional information received, annulus of the patient was 25 mm.No malfunction of the device has been reported and approximately 30-40 min was added to the procedure.Reportedly, patient remained stable through the procedure and is doing well.
Additional Manufacturer Narrative
The device was returned to the manufacturer.The hydrodynamic testing was conducted on the returned pvf-l.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 3.30 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 6.9% 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.Comparing the images of the fluidic test, performed on the returned valve, with those ones of the release test (steady flow test), a slight difference can be observed in the opening of the leaflet in correspondence with post i.This particular geometry, more visible in hypotensive conditions, is not found in the images of the steady flow test, suggesting that it may be due to small deformations induced during the explantation phases of the prosthesis itself or due to non-optimal storage conditions which could have make the leaflet stiffer in that area.However, this aspect does not alter in any way the closing configuration of the leaflets themselves.It follows that it cannot in any way be attributed as a possible cause of the observed and complained ''mild central leak''.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 medical judgement received ''the valve may have undersized initially'', it is possible that the cause of the reported event was attributed to the mis-sizing (use-error).

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: 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: 14623356
• Report Number: 3004478276-2022-00155
• Device Sequence Number: 20070946
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)251211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2025
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown