MAUDE Adverse Event Report: LIVANOVA CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	DLA19
Medical Device Problem Codes	Degraded (1153); Gradient Increase (1270)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/21/2018
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2014 a patient received a mitroflow dla19 as part of an avr.The manufacturer was notified that on the (b)(6) 2018 the patient passed away due to cardiovascular mortality, structural valve deterioration.No autopsy was performed.
Event or Problem Description
The manufacturer received additional information on (b)(6)2020 identifying the following.The patient had an increase in dyspnea as well as angiogenic palpitations.The svd was identified through an increasing transvalvular gradient.In 2015 10 mmhg, 2016 31 mmhg, 2017 39 mmhg, and 2018 : 55 mmhg.No device imaging is available for analysis.The patient death was sudden and a result of respiratory distress.Tomodensitometry identified a possible pulmonary infection rather than pulmonary edema.
Additional Manufacturer Narrative
The manufacturer received additional information on (b)(6)2020 identifying the following.The patient had an increase in dyspnea as well as angiogenic palpitations.The svd was identified through an increasing transvalvular gradient.In 2015 10 mmhg, 2016 31 mmhg, 2017 39 mmhg, and 2018 : 55 mmhg.No device imaging is available for analysis.The patient death was sudden and a result of respiratory distress.Tomodensitometry identified a possible pulmonary infection rather than pulmonary edema.The patient medication was betablockers bisoprolol; ara ii: candesartan; aspirin 160 mg.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla19, s/n # 371081, 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.Based on the information received the root cause of death was identified as sudden respiratory distress.As the device is not available for analysis the manufacturer cannot perform any further investigations.As no information regarding the device condition, or factors that may have lead to the increasing gradient are available the manufacturer cannot presently identify the exact root cause of the svd.It is possible that the patient's risk factors (dyslipidemia) contributed to the reported structural valve deterioration.However, since no investigation could be performed, this cannot be ultimately confirmed.Structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 9514180
• Report Number: 1718850-2019-01218
• Device Sequence Number: 19525341
• Product Code: LWR
• UDI-Device Identifier: 00896208000153
• UDI-Public: (01)00896208000153(240)DLA19(17)190531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020
• Report Date (Section F): 11/24/2019

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: 05/31/2019
• Device Model Number: DLA19
• Device Catalogue Number: DLA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2019
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/24/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/04/2020
• 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: Death
• Patient Age: 74 YR
• Patient Weight: 71