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

Model Number	LXA21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2014 a mitroflow lxa21 was implanted.On (b)(6) 2018 the device was explanted and replaced with a crown cna23 aortic heart valve implant.No further information was received.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa23, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa23 mitroflow aortic pericardial heart valve at the time of manufacture and release.Additional information received identified no further information is available.Because the device is not available for return and no further information is available the root cause of the event cannot be determined at this time.If further information is received the case will be reassessed.Fields changed.

• Brand Name: MITROFLOW LXA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7705313
• Report Number: 3004478276-2018-00247
• Device Sequence Number: 19015728
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)180731
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 10/04/2018

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: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: LXA21
• Device Catalogue Number: LXA21
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: 64 YR