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

Model Number	DLA25
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not received.
Event or Problem Description
On (b)(6) 2017 a mitroflow dla25 was implanted.The surgeon decided he did not like the fit of the valve and it was an incorrect size for the patient.They removed it immediately and replaced it with another size of valve.The patient outcome is fine.Added x-clamp time was not specified.
Additional Manufacturer Narrative
The following fields has been modified: since the device has not been returned, the investigation was limited to the device history records review, that showed that this device met the criteria required at the time of manufacturing and release.
Event or Problem Description
On (b)(6), 2017 a mitroflow dla25 was implanted.The surgeon decided he did not like the fit of the valve and it was an incorrect size for the patient.They removed it intraoperatively and replaced it with a sorin mitroflow 23mm valve.The failure to implant added 25 minutes of x-clamp to the procedure and the patient was in a stable condition during explant.The patient outcome is fine.
Additional Manufacturer Narrative
Additional information received apr.17, 2018 stating the following: the device was explanted intra-operatively, 25 minutes of x-clamp time was added to the procedure as a result of the failure to explant, the patient was in a stable condition during explant and a sorin mitroflow 23mm valve was implanted as a replacement.This information has been added to the event description.The manufacturer will perform a device history record review and report its findings upon conclusion.

• Brand Name: MITROFLOW DLA
• 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: 7311849
• Report Number: 3004478276-2018-00140
• Device Sequence Number: 1261081
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)220831
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2018

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: Physician
• Device Expiration Date: 08/31/2022
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 05/29/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/16/2018; 06/01/2018
• 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