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

Model Number	DLA23
Medical Device Problem Codes	Gradient Increase (1270); Material Deformation (2976)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
On (b)(6) 2014 a patient received a mitroflow dla23.On (b)(6) 2019 the patient had a re-operation due to severe ai.The mitroflow was determined on inter-op tee to have sever ai and a mean gradient of 20mmhg.The operation went forward with the mitroflow being removed and a perceval, pvs21 (sn: (b)(4)) being implanted.The operation went smoothly with a mean gradient across the valve of 5mmhg at the end of the case.The physician noted the cause of the failure was not calcification but a torn leaflet near one of the posts.The location of the tear relative to the patients anatomy is unknown.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla23, s/n # (b)(4), 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 dla23 mitroflow aortic pericardial heart valve at the time of manufacture and release.Because the device was not available for return and analysis no further investigations can be performed at this time.Structural valve deterioration (svd) is a known inherent risk of failure for biological valve implants.However, the root cause of the reported svd cannot be determined at this time.

• 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: 8434219
• Report Number: 3004478276-2019-00137
• Device Sequence Number: 1062341
• Product Code: LWR
• UDI-Device Identifier: 00896208000177
• UDI-Public: (01)00896208000177(240)DLA23(17)190131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: 01/31/2019
• Device Model Number: DLA23
• Device Catalogue Number: DLA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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: 73 YR