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

Model Number	DLA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/03/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received patient tracking form on 29 nov 2016 with following information: mitroflow dla, size 25, sn# (b)(4)was implanted at aortic position on (b)(6) 2016 and information about the second implant that mitroflow dla, size 23, sn# (b)(4) was implanted in the same aortic patient at same hospital.No further information was provided.
Event or Problem Description
Follow-up showed that it was likely that in (b)(6) the patient had come back for a mitral valve that he didn¿t fix during the first surgery in (b)(6) and that the aortic valve was likely replaced from oversizing that led to the mitral valve worsening.No other additional details were provided from the surgeon¿s office.

• 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: 6197209
• Report Number: 3004478276-2016-00167
• Device Sequence Number: 376616
• Product Code: DYE
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)171231
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060038/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 12/31/2017
• Device Model Number: DLA
• Device Catalogue Number: DLA25
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 05/18/2017
• 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: 79 YR