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

Model Number	DLA21
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); No Information (3190)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, a female patient received a dla21 in aortic position.The dla21 was explanted on (b)(6) 2019.No further information is presently available.
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.Based on the available information, it is not possible to establish the root cause of the reported event.However, based on the document review performed, no manufacturing defiicts were identified.Livanova is presently following up with the centre to retrieve additional information on this case.If additional information will be received, a follow up report will be submitted.
Additional Manufacturer Narrative
The manufacturer is providing an updated event description based on the additional information received from the site.Since the device is not available for return, no investigation on the device is possible at this time.As such, it is not possible to ultimately confirm the root cause of the reported event.Structural valve deterioration is listed as a possible adverse event in the mitroflow ifu.The event is, therefore, a known inherent risk of the device.
Event or Problem Description
On (b)(6) 2016, a female patient received a dla21 in aortic position.The dla21 was explanted on (b)(6) 2019.The device was explanted due to severe prosthesis stenosis.The explanted device was replaced with a medtronic freestyle root.A good postoperative outcome is reported for this patient, who had a full recovery.The patient has a history of calcific aortic stenosis, but no particular risk factors were identified.

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9164284
• Report Number: 1718850-2019-01100
• Device Sequence Number: 1782999
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)161031
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2019
• Report Date (Section F): 09/11/2019

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: 10/31/2016
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2019
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/11/2019; 09/11/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/25/2019; 12/12/2019
• 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: 70 YR