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

Model Number	DLA21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/31/2018
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) 2014 at the aortic position.On (b)(6) 2018, the valve was explanted and replaced with a solo smart valve.No other information was provided.
Event or Problem Description
A mitroflow dla was implanted on (b)(6), 2014 at the aortic position.On (b)(6), 2018, the valve was explanted and replaced with a solo smart size 21 valve.No other information was provided.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla21, s/n # 373390, 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 dla21 mitroflow aortic pericardial heart valve at the time of manufacture and release.The manufacturer was unable to obtain additional information about the reported event, despite multiple attempts to follow up.As such, the root cause of the event cannot be determined, and the relationship to the device cannot be determined.However, based on the document review performed, no manufacturing deficiencies were identified.Based on the relative dimensions of the dla21 and the solo smart size 21, it is possible that mis-sizing contributed to the reported event.However, due to the limited information provided, and given that the implant position (supra- or intra-annular) of the dla valve is unknown, this cannot be confirmed.Should additional information be received in the future, the case will be re-evaluated and appropriate investigative action will be taken.H3 other text : unable to follow up; not returned.

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8156894
• Report Number: 3004478276-2018-00362
• Device Sequence Number: 19262668
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)160630
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 06/30/2016
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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: 65 YR