MAUDE Adverse Event Report: CORCYM CANADA CORP. MITROFLOW DLA; TISSUE HEAR VALVES

Model Number	DLA21
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of this event through patient tracking.The mitroflow dla21 valve was implanted in the patient on (b)(6) 2017 and explanted due to stenosis on (b)(6) 2021.According to the additional information received, the patient has a history of copd, history of tobacco abuse, coronary artery disease, atrial fibrillation, obesity, chronic diastolic disease.The patient underwent aortic valve replacement, mitral valve replacement, 4 vessel bypass, maze procedure in (b)(6) of 2017.Based on the operational report provided, evaluation and the echocardiography of the patient demonstrated aortic insufficiency, as well as some degree of aortic stenosis.The mitral valve also had mild stenosis and the mitral prosthesis was obstructing the left ventricular outflow tract.Thus, the patient presented for the surgical correction.The patient was stable during the procedure and the operation was performed without any complications.Patient discharged 10 days post-op with stable condition.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEAR VALVES
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 13231941
• Report Number: 3019892983-2022-01006
• Device Sequence Number: 4280108
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2022
• Report Date (Section F): 12/17/2021

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: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2022
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Male