MAUDE Adverse Event Report: CORCYM CANADA CORP. MITROFLOW DLA; TISSUE HEART 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) 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.
Additional Manufacturer Narrative
Device is not available for return to manufacturer.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla21 were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla21 mitroflow aortic pericardial heart valve at the time of manufacture and release.Since the device was not returned to the manufacturer, no further investigation is possible.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, from the document review performed no manufacturing deficiencies were identified.Based on the operative findings that identified a heavily calcified prosthesis, with degenerated leaflets, the root cause of the explant can be traced to structural valve deterioration of the mitroflow valve implanted.It is possible that the patient¿s clinical history and risk factors could have contributed to the early degeneration of the valve as reported in the event, given also the decision to ultimately implant a mechanical valve at the time of the re-do procedure.However, since the device was not available for further investigation, this cannot be ultimately confirmed.It should be noted that structural valve deterioration is listed as a possible adverse event in the mitroflow valve ifu.The event is therefore a known inherent risk of the device.Should any further information be received, the manufacturer will provide a supplemental report as applicable.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEART VALVES
• 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: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13232080
• Report Number: 3004478276-2022-00114
• Device Sequence Number: 17279836
• 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: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2016
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Male