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	09/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified through patient tracking form on (b)(6) 2016 about the following: mitroflow lxa, size 19, sn# (b)(4) was implanted on (b)(6) 2012 at (b)(6).Manufacturer received another patient tracking form that mitroflow dla, size 21, sn# (b)(4) was implanted in same aortic position on (b)(6) 2016.
Additional Manufacturer Narrative
Mitroflow bioprosthetic pericardia heart valve, model lxa19, s/n (b)(4), the partial dhr package review results are within specifications.Attempts were made for additional information but no further details were provided.

• 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
• MDR Report Key: 6197185
• Report Number: 3004478276-2016-00166
• Device Sequence Number: 13697132
• Product Code: DYE
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)151231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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: No Information
• Device Expiration Date: 12/31/2015
• Device Model Number: LXA
• Device Catalogue Number: LXA19
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 07/27/2017
• 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: 78 YR