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

Model Number	DLA21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer was notified of this event via patient tracking, and is in the process of following up to determine additional information about the event.Device disposition presently unknown.
Event or Problem Description
I mitroflow dla21 was implanted on (b)(6) 2015.The valve was explanted on (b)(6) 2017, and replaced with a crown (b)(4).
Additional Manufacturer Narrative
The partial manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla21, s/n # (b)(4) were pulled 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.As the device was not available for return, no further investigation can be performed, and the root cause of this event cannot be determined.However, from the document review performed, no manufacturing deficits were identified.Based on the information provided, it is possible that the event was attributable to a previous, unconfirmed endocarditis.Should the event be attributable to previous endocarditis and reinfection, given the duration of implant (>2.5 years) the event is unlikely to be related to the valve, and more likely to be related to the patient's clinical condition and predisposing risk factors.However, ultimately the root cause of the event cannot be determined without investigating the device.Device not available for return.
Event or Problem Description
Additional information was received on february 2, 2018 indicating that the device was explanted due to stenosis, possibly resulting from re-infection due to a previous unconfirmed endocarditis.Because the endocarditis was not confirmed, no date for the event was available.The indications for endocarditis were not reported.The patient's outcome was reported to be good/satisfactory.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7236443
• Report Number: 3004478276-2018-00123
• Device Sequence Number: 10791118
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)161130
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: LWR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: 11/30/2016
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/28/2018
• 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
• Patient Age: 48 YR