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

Model Number	DLA25
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition not presently known.
Event or Problem Description
A mitroflow dla was implanted on (b)(6) 2015.At discharge the patient's mean gradient was reported to be 9 mmhg with no central or paravalvular leak.At one-year follow-up on (b)(6) 2016, the mean gradient was 30 mmhg, and at two-year follow up on (b)(6) 2017, the mean gradient was 25 mmhg, with no central or paravalvular leak.On (b)(6) 2017 the valve was explanted due to structural valve deterioration.The valve was reportedly calcified.The patient was reported to have a systolic pulmonary arterial pressure was <50 mmhg prior to vale implant.Patient had pre-operative dyslipidemia.The patient was not at risk for patient prosthesis mismatch.The valve was reportedly explanted at an outlying hospital.Records of the explant were requested by the implanting site, but not received at the time of reporting.
Event or Problem Description
The manufacturer received confirmation that the reporting site did not receive any information about the device explant, which was performed by an outlying hospital.
Additional Manufacturer Narrative
The research department at the reporting site confirmed that the valve is not available for return and analysis because patient was not admitted in the same hospital where it had its implant, and no information was forwarded to them.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 canada 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.Structural dysfunction is the major cause of failure for bioprosthetic heart valves.The principal underlying cause is cuspal calcification.It is possible that the patient's clinical condition and risk factors (pre-operative dyslipidemia) contributed to the reported event; however, as limited information was received and the device was not available for analysis, the root cause of the event cannot be determined.

• 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: 7714776
• Report Number: 3004478276-2018-00254
• Device Sequence Number: 19099058
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)161231
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: 12/31/2016
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: 76 YR
• Patient Weight: 85