MAUDE Adverse Event Report: LIVANOVA CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	CNA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During aortic valve replacement, a crown valve size 23 was implanted using a running suture technique.In the intra-operative trans esophageal echocardiogram (tee), a leak was detected.The surgeon decided to remove the valve and re-implant it using a non everting interrupted suture with pledgets, but again the intra-operative tee showed a regurgitation similar to the previous one with regard to location and severity.During this second attempt, it was clarified that the regurgitation was located centrally.Due to high risk patient, the surgeon decided to explant the device and did not try to implant another crown 23mm (in order to prevent a fourth cross-clamping in case of failure).He eventually implanted a different valve (mosaic).The surgeon excluded any relationship between the anatomical features of the patient and the device.He thinks that the problem was most likely related to that specific device.
Additional Manufacturer Narrative
The device was received for analysis on march 21, 2017 and a gross examination was performed.
Additional Manufacturer Narrative
The returned valve was received without any kind of storage liquid and totally dehydrated without any possible leaflet movement therefore no additional analysis was able to be performed on the returned valve.The complete manufacturing and material records for the crown prt aortic pericardial heart valve, model cna23 , (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.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6408387
• Report Number: 3004478276-2017-00023
• Device Sequence Number: 18839380
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)211021
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: CNA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 04/20/2017; 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