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	06/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, this event is being reported in a conservative manner.Not yet determined if device available.
Event or Problem Description
On (b)(4) 2017 the manufacturer was notified by patient tracking of a mitroflow lxa21 that was implanted on (b)(6) 2013 and explanted on (b)(6) 2017, after 4.27 years.A pvs21 was then implanted.No further information is known at present.
Additional Manufacturer Narrative
The partial manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa21, s/n # (b)(4), were retrieved and reviewed by quality engineering at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa21 mitroflow aortic pericardial heart valve at the time of manufacture and release.The device is not available for return and no further information will be provided to the manufacturer on this event.No further investigation is possible at this time.Not available for return.
Event or Problem Description
On 13 jun 2017 the manufacturer was notified by patient tracking of a mitroflow lxa21 that was implanted on (b)(6) 2013 and explanted on (b)(6) 2017 due to early calcification, after 4.27 years.A pvs21 was then implanted.No further information will be provided.

• 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 V5J5M 1; CA V5J5M1
• MDR Report Key: 6699706
• Report Number: 3004478276-2017-00132
• Device Sequence Number: 13702802
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/15/2017

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: 06/13/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 11/15/2017
• 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: 67 YR