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

Model Number	DLA25
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Stroke/CVA (1770); Endocarditis (1834)
Date of Event	10/19/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device disposition not presently known.
Event or Problem Description
A mitroflow dla25 was implanted on (b)(6) 2018.At discharge the patient had a mean gradient of 7.0 mmhg, and was in nyha class ii.On (b)(6) 2016, the patient's mean aortic gradient was 16 mmhg, and the patient was in nyha class iii.The patient died on (b)(6) 2016, due to an apparently non-device related event.
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.Because no autopsy was performed and the device cannot be analyzed no further investigations are possible at this time.In addition the manufacturer was unable to acquire any further information from the site regarding the reported events.Because no further information is available and no further investigations can be performed the exact root cause of the patient death and other reported adverse events cannot be determined.If further information is received the investigation will be reassessed.

• 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: 7741256
• Report Number: 3004478276-2018-00267
• Device Sequence Number: 1618916
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)190228
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 90