MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW DLA; TISSUE HEART VALVE

Model Number	DLA21
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); No Information (3190)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2016 a patient received a mitroflow dla21 aortic heart valve implant as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a carbomedics s5-025 mechanical heart valve prosthesis.No further information was received.
Event or Problem Description
On (b)(6) 2016 a patient received a mitroflow dla21 aortic heart valve implant as part of an avr.The manufacturer was notified that the device was explanted on march 25, 2020 and replaced with a carbomedics s5-025 mechanical heart valve prosthesis.The manufacturer received the operation report identifying the following.Pre-operative diagnosis was for critical aortic stenosis, severely reduced left ventricular ejection fraction (15%), bioprosthetic valve degeneration, influenza type a infection.The site performed a 3rd time redo sternotomy with an aortic root re-replacement using composite mechanical valved conduit (25mm carbomedics top-hat +28mm gelweave valsalva).The post-operative gradient was 15mmhg via tee and the patient was transported back to thoracic intensive care in a stable but critical condition.
Additional Manufacturer Narrative
The manufacturer received the operation report identifying the following.Pre-operative diagnosis was for critical aortic stenosis, severely reduced left ventricular ejection fraction (15%), bioprosthetic valve degeneration, influenza type a infection.The site performed a 3rd time redo sternotomy with an aortic root re-replacement using composite mechanical valved conduit (25mm carbomedics top-hat +28mm gelweave valsalva).The post-operative gradient was 15mmhg via tee and the patient was transported back to thoracic intensive care in a stable but critical condition.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla21, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.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 valve was not available for return or analysis, no further investigation can be performed at this time.It is possible that the patient's risk factors contributed to the reported structural valve deterioration.However, since no investigation could be performed, this cannot be ultimately confirmed.Structural valve deterioration is listed as a possible adverse event in the device ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10090022
• Report Number: 3004478276-2020-00159
• Device Sequence Number: 19545753
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 10/31/2017
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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
• Patient Age: 57 YR