MAUDE Adverse Event Report: CORCYM CANADA CORP. MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	DLA19
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla19, s/n # (b)(4), as they pertain to the reported event, 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 dla19 mitroflow aortic pericardial heart valve at the time of manufacture and release.
Event or Problem Description
On (b)(6) 2014, a mitroflow valve dla19 was implanted in aortic position.In 2014 the patient had aortic valve failure, calcification and severe fatigue.As reported, the patient has been in heart failure 2 years post op, and was taken to hospital on (b)(6) 2021 with trouble breathing while seated.The valve was not explanted as there was a very high mortality rate.Based on the echocardiogram reports provided on (b)(6) 2016 an echo showed moderate eccentric aor (paravalvular), the peak gradient was 60mmhg the mean gradient was 33mmhg.It also showed severe aortic bioprosthesis dysfunction with moderate paravalvular leak and at least moderate aortic stenosis.It was also noted that the patient had moderate central mr and moderate pulmonary hypertension with moderate to severe tricuspid regurgitation (tr).Based on this echo there was significant worsening since the previous study.On (b)(6) 2019 the echo showed evidence of severe stenosis of the aortic valve prosthesis, mild paravalvular aortic regurgitation, mean gradient is 31mmhg.It was also noted that the patient had mitral annular calcification and moderate mitral regurgitation.On (b)(6) 2021 the echo showed that the rcc is immobile, gradients are elevated across the valve, mild central ai and moderate paravalvular ai.The mean gradient is 36mmhg and there was moderate to severe mr and severe tr.

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL 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: 12438750
• Report Number: 1718850-2021-01202
• Device Sequence Number: 11657215
• Product Code: LWR
• UDI-Device Identifier: 00896208000153
• UDI-Public: (01)00896208000153(240)DLA19(17)160731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2021
• Report Date (Section F): 08/12/2021

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: 07/31/2016
• Device Model Number: DLA19
• Device Catalogue Number: DLA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2021
• 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: Other