MAUDE Adverse Event Report: LIVENOVA CANADA CORP MAPHV WITH PR TREATMENT, A19; MITROFLOW TISSUE HEART VALVE

Model Number	DLA19
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discharged by the hospital.
Event or Problem Description
Mitroflow valve dla19 was implanted on (b)(6) 2015.Patient contracted late endocarditis.The valve was explanted after 1.5 years and replaced by cna21 crown.Mitroflow was discarded and is not available for analysis.Patient was discharged.
Additional Manufacturer Narrative
Describe event or problem, initial medwatch inadvertently omitted details of the event.
Event or Problem Description
Patient was non compliant and left the country, contracted late endocarditis.

• Brand Name: MAPHV WITH PR TREATMENT, A19
• Common Device Name: MITROFLOW TISSUE HEART VALVE
• Manufacturer (Section D): LIVENOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6531895
• Report Number: 3004478276-2017-00067
• Device Sequence Number: 18890034
• Product Code: LWR
• UDI-Device Identifier: 00896208000153
• UDI-Public: (01)00896208000153(240)DLA19(17)161231
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: DLA19
• Device Catalogue Number: DLA19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 07/19/2017
• 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: Required Intervention
• Patient Age: 58 YR