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

Model Number	PVS25
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 15504928
• Report Number: 3019892983-2022-01043
• Device Sequence Number: 12076198
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)230320
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2022
• Report Date (Section F): 08/31/2022

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: 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
• Distributor Facility Aware Date: 08/31/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown