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

Model Number	LXA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
The manufacturer received a 2nd patient registration form (prf) for aortic position for same patient.Details as following: lxa19 sn# (b)(4) was implanted on (b)(6) 2014 at (b)(6) at the aortic position.S5-021 sn# (b)(4) was implanted on (b)(6) 2016 at (b)(6) at the aortic position for same patient.No further information is available.
Additional Manufacturer Narrative
Design history record review completed mar 29, 2017.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) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model lx) mitroflow aortic pericardial heart valve at the time of manufacture and release.

• 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: 6064966
• Report Number: 3004478276-2016-00131
• Device Sequence Number: 18930374
• Product Code: DYE
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)180930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2017

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: 09/30/2018
• Device Model Number: LXA
• Device Catalogue Number: LXA19
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2016
• Supplement Report FDA Received Date: 04/10/2017
• 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: 72 YR