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

Model Number	DLA19
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2016 a patient received a mitroflow dla19 as part of an avr.The manufacturer was notified via the patient tracking system that the device was explanted on (b)(6) 2019 and replaced with a perceval pvs21 sutureless aortic heart valve implant.No further information was received.
Additional Manufacturer Narrative
The manufacturer made several attempts to contact the physician for additional information and no further information was received.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model#: dla19, 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 dla19 mitroflow aortic pericardial heart valve at the time of manufacture and release.Because no further information is available and the device is not available no further investigations are possible and the root cause can not be determined at this time.If further information is received at a later date the manufacturer will update the competent authority and reassess the case.

• 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: 9349536
• Report Number: 3004478276-2019-00310
• Device Sequence Number: 14162403
• Product Code: LWR
• UDI-Device Identifier: 00896208000153
• UDI-Public: (01)00896208000153(240)DLA19(17)160630
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 02/25/2020

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: 06/30/2016
• Device Model Number: DLA19
• Device Catalogue Number: DLA19
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: 82 YR