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

Model Number	LXA
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information through patient tracking form on 29 nov 2016 : received the 2nd patient registration form for a patient with following details: lxa19 sn # (b)(4) was implanted.There was no implant date available, but initial patient registration form was received on sep 5, 2012.Pvs21 sn # (b)(4) was implanted on (b)(6) 2016 at same aortic location.No further information was provided.
Additional Manufacturer Narrative
The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa19, s/n # (b)(4), were pulled and reviewed by quality control at livanova (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa19 mitroflow aortic pericardial heart valve at the time of manufacture and release.It was indicated that the valve was explanted due to ¿early¿ calcification.No other information was provided.

• 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
• MDR Report Key: 6197214
• Report Number: 3004478276-2016-00165
• Device Sequence Number: 1419054
• Product Code: DYE
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)170228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060038/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: No Information
• Device Expiration Date: 02/28/2017
• Device Model Number: LXA
• Device Catalogue Number: LXA19
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 08/23/2017
• 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: 71 YR