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

Model Number	CNA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on 21 sep 2016 about the following event: after spontaneous circulation was resumed following valve replacement, regurgitation occurred: on (b)(6) 2016: an aortic valve replacement procedure was started for the patient, who was diagnosed with aortic regurgitation and as being suspicious for takayasu's arteritis; as the 25-mm sizer was able to pass through the patient's annulus, the cna23 model was selected; after the patient was confirmed to have takayasu's arteritis, the crown prt cna23 was implanted using everting mattress suture technique; after the patient's spontaneous circulation was resumed, aortic regurgitation occurred and the patient had ventricular tachycardia.The right coronary cusp of the valve appeared to be deformed and showed abnormality in its motion.Regurgitation from the right side of the valve was confirmed; with extracorporeal circulation started again, the crown prt valve was explanted.The patient's aortic wall was weak, and a tear was found on the right side of the aortic wall.The length of this tear was corresponding to one stitch of the suture that was sewn to implant the crown prt valve; crown prt valve, size 23 was explanted and magna ease 23 mm was implanted instead.
Additional Manufacturer Narrative
The complete manufacturing and material records for the crown prt aortic pericardial heart valve, model cna23, 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 crown prt aortic pericardial heart valve at the time of manufacture and release.The visual inspection 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 en iso (b)(4).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: 6049311
• Report Number: 3004478276-2016-00120
• Device Sequence Number: 16222319
• Product Code: DYE
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)170930
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060038/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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: 09/30/2017
• Device Model Number: CNA
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 07/26/2017
• 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: 73 YR