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

Model Number	DLA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Manufacturer was notified of the following information on 23 sep 2016: a (b)(6) patient was implanted with dla27 and mitroflow valsalva conduit on (b)(6) 2014.Dla27 was explanted on (b)(6) 2016 at patient's age of (b)(6) and replaced with mechanical valve.Patient had series of embolic events leading to approximately 5 strokes.No further information was provided.
Event or Problem Description
On november 20, 2016, manufacturer received further information that the patient presented a series of embolic events leading to 5 strokes, those events required anticoagulation therapy first with dabigatran and then with warfarin and aspirin (these double treatment was started after the 5th stroke).Since the intra-valvular gradient appeared slightly increased from the time of valve implant, the decision was taken to explant the mitroflow valve and implant a mechanical valve.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 6049304
• Report Number: 3004478276-2016-00121
• Device Sequence Number: 10841882
• Product Code: DYE
• UDI-Device Identifier: 00896208000191
• UDI-Public: (01)00896208000191(240)DLA27(17)181231
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P060038/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2016

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: 12/31/2018
• Device Model Number: DLA
• Device Catalogue Number: DLA27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 12/08/2016
• 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: 43 YR