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

Model Number	DLA23
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2013, a patient received a mitroflow dla23 in aortic position.The site reports that structural valve deterioration/leaflet stiffened (calcified) was detected on (b)(6) 2018.The clinical status and consequences are reportedly unknown.The echo performed on this date showed a mean gradient of 50mmhg, eoa of 1 cm2, and ejection fraction of 65%.The device functionality was checked again on 23 sep 2019 and a mean gradient of 70mmhg was detected, with a eoa 0.4 cm2 and ejection fraction of 70%.There is no evidence of device explant on the study database.Per additional information received, it was confirmed that the mitroflow valve remains implanted in the patient.This prosthesis presents a degeneration of a tight stenosis type with an average gradient at 84mmhg, vmax at 5.6m / s and a surface area of 0.36cm2.The prosthesis also presents a 2/4 aortic regurgitation.Due to the patient's advanced age, a new surgical replacement is not considered.Moreover, because of an unfavorable coronary anatomy, the patient does not qualify for a tavi.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla23, 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 dla23 mitroflow aortic pericardial heart valve at the time of manufacture and release.Since the device remains implanted, no inspection on the device is possible at this time.Based on the available information, a definitive root cause for the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficits were identified.It is possible that the patient's clinical history and risk factors (i.E.Diabetes; obesity; coronary artery disease) contributed to the reported event.However, since no inspection on the device was possible, the root cause cannot be ultimately stated.It should be noted that structural valve deterioration is listed as a potential adverse event in the mitroflow valve ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10980546
• Report Number: 3004478276-2020-00248
• Device Sequence Number: 14324273
• Product Code: LWR
• UDI-Device Identifier: 00896208000177
• UDI-Public: (01)00896208000177(240)DLA23(17)180731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 07/31/2018
• Device Model Number: DLA23
• Device Catalogue Number: DLA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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: Other
• Patient Age: 86 YR
• Patient Weight: 90