MAUDE Adverse Event Report: LIVANOVA CALNADA CORP MITROFLOW VALVE MODEL LXA19; TISSUE HEART VALVE

Model Number	LXA19
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this case, the mitroflow lxa19 installation did not follow the indicated label instructions for two reasons: 1.The valve was used in the pulmonary valve location, which qualifies as off-label use because, based on the ifu for mitroflow lxa, indications specify that the mitroflow aortic pericardial heart valve is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.2.The warnings and precautions for mitroflow lxa also state the following: clinical experience described in the medical literature suggests that juvenile patients or patients who are undergoing chronic hemodialysis, who have parathyroid disease or impaired calcium metabolism, or who are 55 years of age or less may experience accelerated calcification of bioprosthetic heart valves.The valve was used in a pediatric case and did not follow the stated precautions.
Event or Problem Description
Mitroflow lxa19 was explanted from a pediatric patient after 3.9 years due to inefficiency (implant position was pulmonary - off label use) and replaced by a 25mm valve instead (model and brand are unknown).The device will not be returned and no more information will be provided.
Additional Manufacturer Narrative
The device was not returned and the physician does not want to provide any more information.The partial 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.Review of the function test video and images of the valve were acceptable per the inspection criteria.This was an off-label use of the tissue valve, therefore, no investigation is necessary.

• Brand Name: MITROFLOW VALVE MODEL LXA19
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CALNADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6577317
• Report Number: 3004478276-2017-00087
• Device Sequence Number: 1088797
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/15/2017

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: 10/31/2017
• Device Model Number: LXA19
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 08/15/2017
• 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: 11 YR