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

Model Number	LXA25
Medical Device Problem Codes	Gradient Increase (1270); Material Too Rigid or Stiff (1544); Material Deformation (2976)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Respiratory Failure (2484)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A 25 mm mitroflow lxa was implanted on (b)(6) 2010.On (b)(6) 2018, the valve was explanted due to critical aortic stenosis.Urgent surgery was required due to respiratory collapse.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa25, 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 lxa25 mitroflow aortic pericardial heart valve at the time of manufacture and release.The manufacturer has not received the device for analysis, to date.Given the limited information provided, and the inability to perform a device investigation, the root cause of the event cannot be determined.

• 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: 7515715
• Report Number: 3004478276-2018-00191
• Device Sequence Number: 16477245
• Product Code: LWR
• UDI-Device Identifier: 00896208000122
• UDI-Public: (01)00896208000122(240)LXA25(17)150531
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 06/19/2018

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: 05/31/2015
• Device Model Number: LXA25
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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