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

Model Number	DLA25
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Regurgitation (1716); Stroke/CVA (1770); Endocarditis (1834); Bone Fracture(s) (1870); Hemothorax (1896); Heart Failure (2206)
Date of Event	01/14/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device not explanted.
Event or Problem Description
The manufacturer was notified of the following series of events via the sure avr patient registry.A mitroflow dla size 25 was implanted on (b)(6) 2013.On (b)(6) 2016, the patient experienced cardiac decompensation.On (b)(6) 2016 the patient experienced chest trauma with rib fractures and hemothorax, and on (b)(6) 2017 the patient passed away due to worsening heart failure.The patient had a history of ischemic stroke ((b)(6) 2014) and endocarditis ((b)(6) 2015).According to the information in the registry, at a follow up visit on (b)(6) 2015, the valve was functioning well.On (b)(6) 2016, paravalvular leak (2+) and central leak (2+) with svd were reported.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla25, s/n (b)(4), , as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla25 mitroflow aortic pericardial heart valve at the time of manufacture and release.The manufacturer was unable to obtain additional information about this event, despite attempts to follow up with the involved physician.This event was reported in a conservative manner due to the limited information available.Based on the information provided in the registry, the patient's death was attributed to "proximate cardiac cause".Furthermore, the patient's complicated clinical history (section 12) suggests that patient factors likely contributed to this event.As such, there is no clear indication that the event was device-related.No manufacturing deficits were identified in the document review performed.However, given the limited information available, the root cause of the event cannot be determined.Should further information be received in the future, the case will be revisited and appropriate investigative actions will be taken.

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7515856
• Report Number: 3004478276-2018-00192
• Device Sequence Number: 1254520
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)180630
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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: Death
• Patient Age: 83 YR
• Patient Weight: 94