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

Model Number	DLA23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposed of by site.
Event or Problem Description
On (b)(6) 2016 a patient received a mitroflow dla23 aortic heart valve implant as part of an avr.The manufacturer was notified that on (b)(6) 2019 the valve was explanted due to thrombus.No new implant information was provided.The event occurred at (b)(6) hospital and involved dr.(b)(6).
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla23, s/n # (b)(4), 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 dla23 mitroflow aortic pericardial heart valve at the time of manufacture and release.
Additional Manufacturer Narrative
Updated summary based on information received oct.28, 2019 (added to b5): on (b)(6) 2016 a patient received a mitroflow dla23 aortic heart valve implant as part of an avr.The manufacturer was notified that on mar.29, 2019 the valve was explanted due to thrombus.No new implant information was provided.The event occurred at (b)(6) hospital and involved dr.(b)(6).The manufacturer received identification that this was an event of early explant due to svd.No further information is available.Conclusion: because there is no further information and the device is not available for return no further investigations can be performed at this time.Structural valve deterioration is a known inherent risk of device for biological valve implantation.However, at this time based on the investigations possible and the information available the root cause of the reported svd event cannot be established at this time.
Event or Problem Description
On (b)(6) 2016 a patient received a mitroflow dla23 aortic heart valve implant as part of an avr.The manufacturer was notified that on mar.29, 2019 the valve was explanted due to thrombus.No new implant information was provided.The event occurred at wvu ruby memorial hospital and involved dr.(b)(6).The manufacturer received identification that this was an event of early explant due to svd.No further information is available.

• 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: 8824739
• Report Number: 3004478276-2019-00225
• Device Sequence Number: 16945422
• Product Code: LWR
• UDI-Device Identifier: 00896208000177
• UDI-Public: (01)00896208000177(240)DLA23(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 11/25/2019

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: 11/30/2017
• Device Model Number: DLA23
• Device Catalogue Number: DLA23
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/07/2019; 10/28/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/04/2019; 11/25/2019
• 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: 52 YR