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

Model Number	CNA19
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a mitroflow cna19 was implanted in aortic position; the patient has also received a competitor's valve in the mitral position.The manufacturer was informed that the device was explanted on (b)(6) 2020 due increase in pressure difference.At the time of the re-intervention, when the aorta was opened, the stent post of crown cna19 valve was found fallen inward and the valve itself had twisted resulting in stenosis.The patient ultimately received a perceval pvs21.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada 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.
Additional Manufacturer Narrative
The device involved in the reported event was returned to the manufacturer for investigation.After decontamination, the prosthesis was visually inspected and appeared deformed.The stent was then removed from pericardium tissue and it was visually inspected to confirm its integrity.After removal from the pericardium and dacron, the inspection performed on the stent confirmed the absence of breaks despite a significant deformation.A dimensional and geometrical analysis was conducted by means of profile projector in order to verify and document the shape and dimension of the deformity.The visual inspection performed confirmed the absence of pre-existing manufacturing defects or structural breakage.Based on the performed analysis, the cause of the stent deformation can be reasonably associated to a mishandling ¿ a squeeze of the post i and iii of the prosthesis, in radial direction and to the center of the valve ¿ that occurred at the time of the implant procedure.This manipulation resulted in a permanent deformation that compromised the correct kinematic behavior of the prosthesis.

• 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: 10972608
• Report Number: 1718850-2020-01211
• Device Sequence Number: 14261700
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)201231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2021
• Report Date (Section F): 11/11/2020

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: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/11/2020; 02/27/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/15/2021; 02/27/2021
• 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: 84 YR
• Patient Weight: 56