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

Model Number	CNA
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a mitroflow valve implanted on (b)(6) 2017 and explanted two weeks later on (b)(6) 2017.It was stated that at implantation the valve seemed fine.After w weeks before discharge, there was aortic insufficiency.The patient had a prolonged hospital stay due to decompensation.It was also stated that on the tee the leaflets seemed to be asymmetric and one (right) coronary cusp seemed open.A perimount magna ease valve was implanted instead.
Additional Manufacturer Narrative
The results of the document review for the crown prt cna25 ¿ sn (b)(4) confirmed that the device satisfied all material, dimensional and performance standards required for a crown prt valve size 25 at the time of manufacture and release.This included the function test of the valve by quality control in a hydrodynamic tester performed on (b)(6) 2016.The visual inspections performed on the returned prosthesis confirmed the absence of manufacturing defects.The hydrodynamic testing conducted on the returned prosthesis confirmed that the device was showing a normal leaflet kinematics with a regurgitation fraction in compliance with requirement of iso 5840:2015.No malfunction or abnormal kinematics was observed.Based on the performed analysis the reported event cannot be explained by any factor intrinsic in the involved device.

• 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: 6545852
• Report Number: 3004478276-2017-00075
• Device Sequence Number: 13607161
• Product Code: LWR
• UDI-Device Identifier: 00896208000535
• UDI-Public: (01)00896208000535(240)CNA25(17)211031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/23/2017

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: Physician
• Device Expiration Date: 10/31/2021
• Device Model Number: CNA
• Device Catalogue Number: CNA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 06/23/2017
• 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: 70 YR
• Patient Weight: 85