MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MAPHV WITH PR TREATMENT, A27; TISSUE HEART VALVE

Model Number	DLA
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); No Information (3190)
Date of Event	12/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The manufacturer was notified that the patient's device was implanted on (b)(6) 2014 and explanted (b)(6) 2016.
Additional Manufacturer Narrative
The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla27, s/n # (b)(4), were pulled and reviewed by quality control at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla27 mitroflow aortic pericardial heart valve at the time of manufacture and release.Based on the review of records performed, no manufacturing defects were identified.As the device is not available for return, no further investigation can be performed and the root cause of the event cannot be determined.However, due to the late onset of endocarditis (2.44 years after implant) it is unlikely that this event was device related and no further investigation is required.Device evaluated by manufacturer.Device not available for return.
Event or Problem Description
The manufacturer was notified that a mitroflow dla27 was implanted on (b)(6) 2014 and explanted (b)(6) 2016 due to endocarditis.Upon explant, the valve reportedly "looked fine, besides a little bit of vegetation growing on the side." because it was not a structural deterioration problem, they reportedly implanted another bioconduit successfully.The valve was replaced with a mitroflow dla25, and the bioconduit implanted was a mitroflow valsalva of corresponding size.

• Brand Name: MAPHV WITH PR TREATMENT, A27
• 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: 6298654
• Report Number: 3004478276-2017-00007
• Device Sequence Number: 1105880
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)140501
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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: 05/01/2014
• Device Model Number: DLA
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 10/23/2017
• 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: 62 YR