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

Model Number	LXA19
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa19, 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 lxa19 mitroflow aortic pericardial heart valve at the time of manufacture and release.As the device was not received for analysis, no further investigation can be performed.Based on the document review performed, no manufacturing deficits were identified.However, as the device was not received for analysis and limited event information was provided, the root cause of this event cannot be determined.
Event or Problem Description
A mitroflow lxa19 was implanted on (b)(6) 2012.On (b)(6) 2015, the valve was explanted and replaced with a crown cna19 valve.No further information about the event was available.

• Brand Name: MITROFLOW LXA
• 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: 7429822
• Report Number: 3004478276-2018-00174
• Device Sequence Number: 19320071
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)160413
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 04/13/2016
• Device Model Number: LXA19
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2015
• Initial Report FDA Received Date: 04/13/2018
• 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: Hospitalization; Required Intervention