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

Model Number	DLA25
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported in a conservative manner due to indications of structural valve deterioration.The patient is being monitored and follow-up is being conducted regarding the patient's present condition.Device not explanted.
Event or Problem Description
A mitroflow dla25 was implanted in a (b)(6) year old male on (b)(6) 2014.A recent cardiology report states that valve is showing signs of early svd.The patient is being monitored and will have additional in-hospital tests conducted in a few weeks.
Additional Manufacturer Narrative
The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla25, s/n # (b)(4), were pulled and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla25 mitroflow aortic pericardial heart valve at the time of manufacture and release.The manufacturer received confirmation that there are no plans for re-operation at this time, and the patient is being monitored.As such, no the device has not been explanted and no further investigation can be performed at this time.However, based on the document review performed, no manufacturing deficits were identified.If re-operation is performed in the future, appropriate investigative actions will be taken.

• 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: 6974681
• Report Number: 3004478276-2017-00174
• Device Sequence Number: 16443317
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)180930
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: 09/30/2018
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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: 61 YR