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

Model Number	DLA
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified through patient tracking on (b)(6) 2016 about the following: on (b)(6) 2016, mitroflow dla size 27, sn# (b)(4) was implanted at aortic position.On (b)(6) 2016, crown prt, size 25, sn# (b)(4) was implanted at the same aortic position at same hospital.No further information was provided.
Additional Manufacturer Narrative
A review of the device history record for the mitroflow bioprosthetic pericardial heart valve, model dla27, s/n (b)(4) as it relates to the reported event, was performed.The review confirmed that the device was within specifications at the time of manufacture and release.The manufacturer was unable to obtain further information about this case, despite attempts to follow up.However, based on the document review performed, no manufacturing deficits were identified.Furthermore, according to the information available, the mitroflow dla27 was explanted and replaced with a crown cna25.Based on this information, it is possible that mis-sizing contributed to this event; however, without further information the root cause of the event cannot be confirmed.As the device was not returned for analysis, no further investigation can be performed at this time.Should additional information become available at a later date, or if the device is returned for analysis, appropriate investigative actions will be taken.Unable to follow up; not returned.

• 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: 6197222
• Report Number: 3004478276-2016-00168
• Device Sequence Number: 13608827
• Product Code: DYE
• UDI-Device Identifier: 00896208000191
• UDI-Public: (01)00896208000191(240)DLA27(17)160831
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/29/2016

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: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: DLA
• Device Catalogue Number: DLA27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 12/14/2017
• 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: 59 YR