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

Model Number	LXA21
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Limited information is known to the manufacturer at present for this event and further information is being requested from the physician.Please note as per mitroflow aortic pericardial heart valve model lx instructions for use , the following is stated: " warnings and precautions 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." not yet determined if device available.
Event or Problem Description
On (b)(6), the manufacturer received notification through patient tracking of a mitroflow lxa21 that was implanted on (b)(6) 2013 and explanted on (b)(6) 2017 for a pediatric patient.
Additional Manufacturer Narrative
This device was implanted in the pulmonary position of a pediatric patient, in this case the implantation of the device did not follow the ifu for two reasons: 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.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.Device discarded by hospital.
Event or Problem Description
The valve was explanted from the pulmonary position due to an obstruction(calcification) and replaced with a pulmonary homograft.The patient has been discharged.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6850199
• Report Number: 3004478276-2017-00158
• Device Sequence Number: 16174351
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)171130
• 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): 09/15/2017

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: 11/30/2017
• Device Model Number: LXA21
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/15/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 7 YR