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

Model Number	DLA21
Medical Device Problem Codes	Calcified (1077); Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Information (3190)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2018 a patient received a mitroflow dla21 aortic heart valve implant as part of a aortic valve replacement.The manufacturer was notified that on (b)(6) 2019 the device was explanted and replaced with a carbomedics top hat s5-023 mechanical heart valve.This event occurred at (b)(6) hospital and involved (b)(6).
Event or Problem Description
On (b)(6) 2018 a patient received a mitroflow dla21 aortic heart valve implant as part of a aortic valve replacement.The manufacturer was notified that on (b)(6) 2019 the device was explanted and replaced with a carbomedics top hat s5-023 mechanical heart valve.Additional information received on aug.07, 2019 identifying the following information.The device was explanted due to leaflet calcification.The patient outcome was a successful carbomedics top hat implantation.The device is not available for return.
Additional Manufacturer Narrative
Additional information received on aug.07, 2019 identifying the following information.The device was explanted due to leaflet calcification.The patient outcome was a successful carbomedics top hat implantation.The device is not available for return.Fields changed: b4, b5, g4, g7, h2, h6.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla21, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla21 mitroflow aortic pericardial heart valve at the time of manufacture and release.The manufacturer was notified that the device is not available for return and there is no additional event information available.Because no further investigations are possible the root cause of the reported leaflet calcification is unknown.However, structural valve deterioration of biological prosthesis is a known inherent risk of the device.Fields changed: b4, g4, g7, h2, h6.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8827617
• Report Number: 3004478276-2019-00226
• Device Sequence Number: 2510603
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)170731
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2019

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: 07/31/2017
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 09/16/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 09/04/2019; 09/29/2019
• 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: 60 YR