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

Model Number	PVS23
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed that after percival size 23 was implanted on 26 july 2023, the aorta was closed with a double line of sutures.Aortic clamp was removed, but ineffective exit from ecc was noted.Due to massive aortic regurgitation, i.E., overflowing heart, recurrent ventricular fibrillation and a large volume of blood requiring drainage, the aortic clamp was reinserted.The aorta was opened, no abnormality of the prosthesis position was found.The decision was made to explant the valve and replace it with the c-e perimount magna ease 21mm bioprosthesis.Reportedly, the aorta was closed by the blalock method.Output from ecc was smooth.Reportedly, during the visual assessment of the valve after explanation, a clear separation of the petals at the point of fitting was found.
Event or Problem Description
Manufacturer was informed that after perceval size 23 was implanted on (b)(6) 2023, the aorta was closed with a double line of sutures.Aortic clamp was removed, but it was impossible to wean off from ecc and perform tee due to massive aortic regurgitation caused by overflowing heart, recurrent ventricular fibrillation and a large volume of blood requiring drainage from left ventricle, the aortic clamp was reinserted.The aorta was opened, no abnormality of the prosthesis position was found.The decision was made to explant the valve and replace it with the c-e perimount magna ease 21mm bioprosthesis.Reportedly, the aorta was closed by the blalock method.Output from ecc was smooth.Reportedly, during the visual assessment of the valve after explanation, a clear separation of the petals at the point of fitting was found.Based on the further information received, the surgery was through isolated mini sternotomy which extended to full sternotomy.Native valve was steno-insufficient.Reportedly, there were no difficulties in sizing or positioning the perceval prosthesis, and there were no abnormal geometries in patient's annulus.Acc time has been extended by about 60 min, cbp time has been extended by about 100 min.As reported.The postoperative course was uncomplicated, and the patient was discharged home on the 7th day after surgery.Based on the information received, the sizing and correct positioning of the valve was checked, the entire native aortic annulus was covered symetrically by the perceval.The only abnormality that was found was the restriction/asymmetry of one of the perceval bioprosthesis cusp.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2.Conclusion will remain the same.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model # icv1209, 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 has been manufactured and controlled in accordance with the specifications for a model # icv1209 perceval heart valve at the time of manufacture and release.Steady flow test review was also performed.The images demonstrated the acceptable opened and closed leaflet performance of the perceval pvs23 sn# (b)(6).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in the dedicated procedure.The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The hydrodynamic testing was conducted on the pvs 23/m.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 2.61 cm2, 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 2.6% 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 both in normotensive and hypotensive conditions.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because no manufacturing defects were noted during the documents review and no regurgitation and no open/close anomalies were observed during the functional test under hydrodynamic testing conditions.Should further information be received, in the future, a follow up report will be provided.

• Brand Name: PERCEVAL 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 17761018
• Report Number: 3004478276-2023-00177
• Device Sequence Number: 7210624
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)261109
• 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: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 12/06/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 11/06/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/12/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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