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

Model Number	LXA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not yet available for analysis.
Event or Problem Description
The manufacturer was informed on 26 oct 2016 through patient tracking form for patient who had a mitroflow lxa25 implanted in 2012.Details as: lxa25 sn # (b)(4) was implanted on (b)(6) 2012 at (b)(6).R5-023 sn # (b)(4) was implanted on (b)(6) 2016 at (b)(6).No further information provided.
Additional Manufacturer Narrative
The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa25, s/n # (b)(4), were pulled and reviewed by quality control at livanova (b)(4) 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.Further information has been requested from the physician by the manufacturer.Based on limited information received the root cause cannot yet be determined at this time.The device is not available for return or analysis no further investigation is possible at this time.Not available for return.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• 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: 6126457
• Report Number: 3004478276-2016-00155
• Device Sequence Number: 1496579
• Product Code: LWR
• UDI-Device Identifier: 00896208000122
• UDI-Public: (01)00896208000122(240)LXA25(17)161212
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060038/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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: 12/12/2016
• Device Model Number: LXA
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: 04/04/2016
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 11/02/2017
• 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: 54 YR