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

Model Number	DLA23
Medical Device Problem Codes	Degraded (1153); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.
Event or Problem Description
On (b)(6) 2016 a patient received a mitroflow dla23 aortic heart valve implant as part of the sure-avr trial.The manufacturer was notified of a serious adverse event: structural valve deterioration, leaflet stiffening (calcificed), stenosis, patient symptomatic, which occurred on (b)(6) 2019.Per review of the follow-up which occurred on (b)(6) 2019 the patient had a mean gradient of 35 mmhg, central leak 1+, was nyha class iii, and has not had any re-operation.
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.Based on the information available there are no indications that the patient is symptomatic and there are no plans for re-operation.The manufacturer will continue to monitor the patient and if any information is received the manufacturer will reassess the investigation.At this time the root cause of the 1+ leak and increased gradient cannot be determined.

• 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: 9101077
• Report Number: 3004478276-2019-00268
• Device Sequence Number: 2657310
• Product Code: LWR
• UDI-Device Identifier: 00896208000177
• UDI-Public: (01)00896208000177(240)DLA23(17)180531
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 05/31/2018
• 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: 08/21/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: Other
• Patient Age: 70 YR
• Patient Weight: 90