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

Model Number	DLA27
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, this event is being reported in a conservative manner.The manufacturer is in the process of receiving further information from the site on this event.This case was reported to the manufacturer through sure avr database.Device not explanted.
Event or Problem Description
On (b)(6) 2016 a mitroflow dla valve was implanted (27mm) via mini-sternotomy.On (b)(6) 2017 the patient exhibited myocardial infarction- non q wave.This event was reported to the manufacturer on 05-apr-2017.
Additional Manufacturer Narrative
This case was reported to the manufacturer through sure avr registry.This event was reported in a conservative manner, based on limited information received by the manufacturer.The manufacturer requested a medical review of this event for the details that were provided by the site.The medical judgment has determined that the event is due to the patients pre-existing coronary artery disease.(history of coronary pci and pacemaker insertion) and not related to the mitroflow valve which was implanted 1.07 yrs prior to the event.No investigation will be performed for this case as the event has been determined as not device related.Pci, pm implant.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 6549615
• Report Number: 3004478276-2017-00079
• Device Sequence Number: 749617
• Product Code: LWR
• UDI-Device Identifier: 00896208000191
• UDI-Public: (01)00896208000191(240)DLA27(17)170731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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: 07/31/2017
• Device Model Number: DLA27
• Device Catalogue Number: DLA27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 06/07/2017
• 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: Hospitalization
• Patient Age: 82 YR
• Patient Weight: 87