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	09/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information about the reason for explant and information about the returned of the device is not yet available.Manufacturer is reporting in a conservative manner.
Event or Problem Description
Manufacturer received a patient tracking form on oct 17, 2016 with information that a patient who was implanted with mitroflow lxa valve in (b)(6) 2012 got implanted with mechanical valve at same aortic position, at same hospital.Details received on the patient tracking form are as follows: date of implant: device model: sn: 1st implant: (b)(6) 2012, lxa19, (b)(4); 2nd implant: (b)(6) 2016, r5-019, (b)(4).
Additional Manufacturer Narrative
The mitroflow bioprosthetic pericardial heart valve, model lxa19, s/n (b)(4), the partial dhr package review results are within specifications.Attempts were made for more information on the reason for explant, however, no more 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: 6139933
• Report Number: 3004478276-2016-00163
• Device Sequence Number: 161647
• Product Code: DYE
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)161031
• 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: 10/31/2016
• Device Model Number: LXA
• Device Catalogue Number: LXA19
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 12/01/2016
• 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: 72 YR