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

Model Number	PVS27
Medical Device Problem Codes	Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 a perceval pvs7 was implanted into a patient who needed an avr.A high aortotomy was performed and there was significant calcification of the valve, and the right and left coronary cusps were fused.Extensive debridement was required.The annulus was sized to a 23mm inspiris edwards valve, initially a perceval xl was selected to be implanted.The perceval xl was deployed and looked to be in excellent position and the right and left main coronary arteries were unobstructed.Aggressive deairing was performed and the patient still required some defibrillation, as the patient stabilized a moderate central aortic insufficiency was noted.Cross-clamp was reapplied and a cardioplegic arrest was reperformed.Distortion and a crescent-shaping perceval valve was noted and the valve was explanted.Based on additional information no cpr was performed and the patients annulus was 25mm.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12438745
• Report Number: 1718850-2021-01201
• Device Sequence Number: 3578474
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)220418
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021
• Report Date (Section F): 08/11/2021

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: No Information
• Device Expiration Date: 04/18/2022
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2021
• 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