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

Model Number PVS27

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  Injury  

Event 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
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12438745
• MDR Text Key: 270288992
• Report Number: 1718850-2021-01201
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)220418
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/18/2022
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention