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

Model Number DLA23

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 09/27/2015

Event Type  Injury  

Manufacturer Narrative

As the device was not available for return, no device analysis was possible.Furthermore, there was no reported issue with the device according to the follow-up information received.The available information suggests that the initially implanted device was the incorrect size, since the replacement device was not the same size as the initially implanted device.As such, the event is likely attributable to mis-sizing, and is deemed to be not device-related.No further investigation is warranted at this time; however, if further information becomes available in the future, appropriate investigative actions will be taken.

Event Description

The manufacturer was notified of the following event via patient tracking: on (b)(6) 2015 two devices were implanted at the same location (dla23, sn (b)(4) and dla21, sn (b)(4)).There was no indication on the patient registration form of which device remained implanted.Additional information received upon follow-up indicated that the patient outcome was good, and there was no reported issue with the device.No further information was available.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 7135110
• MDR Text Key: 95391656
• Report Number: 3004478276-2017-00221
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000177
• UDI-Public: (01)00896208000177(240)DLA23(17)200430
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: DLA23
• Device Catalogue Number: DLA23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR