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

Model Number	CNA23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gross inspection of the received valve was performed.The returned valve prosthesis was received in general good conditions.Visual analysis and device history record review pending completion.
Event or Problem Description
A mitroflow crown cna23 was implanted in (b)(6).During the procedure the valve was explanted due to an unspecified leaflet malfunction.Another valve was used in replacement.No further information is available at this time.
Additional Manufacturer Narrative
A visual inspection was performed.The visual inspection revealed a cut on the third leaflet, some signs of surgical instruments (i.E.Forceps) on the second leaflet and damage on the post 3 was visible.The thickness of the pericardium tissue was measured and confirmed that the tissue met all specifications required for proper valve coaptation and functionality.The review of the functional test retrieved from dhr, confirmed that the valve leaflets opened fully and coapted properly, showing synchronous opening and closing with smooth, continuous motion and no leaflet fluttering: the valve met the required specifications at the time of the release.The performed hydrodynamic test on the returned valve crown prt sn (b)(4) showed the valve leaflets opened and closed fully with proper coaptation.The returned valve was then disassembled in order to verify the integrity of the stent: it resulted circular without evidence of relevant eccentricity or deformation.The review of the manufacturing and quality control data filed in the device history record of the returned crown prt valve sn (b)(4) confirmed that each manufacturing and inspection operation was followed by the appropriate signature and date, indicating that the process was performed in accordance with livanova specifications, including the mentioned functional test.Based on the performed analysis, resulting in a normal behavior of the valve, the reported issue cannot be explained by any factor intrinsic in the involved device.The valve abnormalities identified above could reasonably be related to the explant procedure, however it is not possible to totally exclude that the damages occurred during the implant steps.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7459083
• Report Number: 3004478276-2018-00176
• Device Sequence Number: 11020559
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)221031
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: 10/31/2022
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 06/07/2018
• 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