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

Model Number	DLA23
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla23, s/n # (b)(4), 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.The manufacturer attempted to retrieve additional information regarding the event but no further information has been received to date.Based on the available information, a definitive root cause for the reported event cannot be established at this time.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.Should additional information be provided in the future, the manufacturer will provide an update to this reporting activity.
Event or Problem Description
The manufacturer was informed on this event through the (b)(6) registry.On (b)(6) 2013, a patient received a mitroflow dla23 in aortic position.The site reports that structural valve deterioration of the device 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 38mmhg, perivalvular leak 1+, eoa of 0.93 cm2, and ejection fraction of 50%.The device functionality was checked again on (b)(6) 2019 and a mean gradient of 50mmhg was detected, with a central leak 1+, eoa 0.7 cm2 and ejection fraction of 65%.There is no evidence of device explant on the study database.
Additional Manufacturer Narrative
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; dyslipidemia) 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.
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 of the device 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 38mmhg, perivalvular leak 1+, eoa of 0.93 cm2, and ejection fraction of 50%.The device functionality was checked again on (b)(6) 2019 and a mean gradient of 50mmhg was detected, with a central leak 1+, eoa 0.7 cm2 and ejection fraction of 65%.There is no evidence of device explant on the study database.The manufacturer received the following additional information from the hospital: the patient did not have a reoperation and the device is still in place.The stenosis degeneration was stable at the last ultrasound check on (b)(6) 2020.It is found a maximum gradient at 74mmhg and mean at 57mmhg and a valvular surface at 0.8cm2.The patient suffers from shortness of breath but is not very troublesome for her activities.Due to the small gene, the stability of the degeneration and the age of the patient (90 years), valve replacement is not considered.

• Brand Name: MITROFLOW DLA VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10971123
• Report Number: 3004478276-2020-00245
• Device Sequence Number: 4258789
• Product Code: LWR
• UDI-Device Identifier: 00896208000177
• UDI-Public: (01)00896208000177(240)DLA23(17)180630
• 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: health professional,study
• 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: 06/30/2018
• 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: 01/22/2021
• Initial Report FDA Received Date: 12/08/2020
• 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: 88 YR
• Patient Weight: 62