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

Model Number	CNA23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: device location not presently known.
Event or Problem Description
The manufacturer was informed on this event through the persist database.On (b)(6) 2017, a female patient received a crown prt in aortic position.At discharge, a good valve functionality is reported (no regurgitation, mean gradient 6mmhg).On (b)(6) 2017, the patient was admitted to the hospital with a fever.It was observed periprosthetic abscess evident at the level of the mitral-aortic junction and extending to the membranous interventricular septum with mobile endocarditic mass jutting into the right atrium (mass length 1.6 cm).No jet, neither shunt was observed.No endocarditis signs were detected in the other valves.The site judged the event related to the procedure and not to the device.A re-intervention was performed on (b)(6) 2017 and the device was explanted.The subject survived at the end of the procedure.
Event or Problem Description
The manufacturer was informed on this event through the persist database.On 24 jul 2017, a female patient received a crown prt in aortic position.At discharge, a good valve functionality is reported (no regurgitation, mean gradient 6mmhg).On (b)(6) 2017, the patient was admitted to the hospital with a fever.It was observed periprosthetic abscess evident at the level of the mitral-aortic junction and extending to the membranous interventricular septum with mobile endocarditic mass jutting into the right atrium (mass length 1.6 cm).No jet, neither shunt was observed.No endocarditis signs were detected in the other valves.The site judged the event related to the procedure and not to the device.A re-intervention was performed on (b)(6) 2017 and the device was explanted.The subject survived at the end of the procedure.The prosthesis was explanted in another site, therefore it is impossible to retrieve additional documentation; the device disposition also remains unconfirmed.However, based on information currently available, no histopathological exam was performed on the explanted prosthesis as the diagnosis of candida infective endocarditis was certain.
Additional Manufacturer Narrative
Fields changed: b4, b5 (updated summary provided based on new information received), g4, g7, h1, h2, h6.The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna23, 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.Based on the event description, the diagnosis was of candida infective endocarditis.If candida species was present on the tissue valve before sterilization, it would be killed very easily by the liquid chemical sterilant used.The sterilant contains a mixture of glutaraldehyde, formaldehyde and alcohol, all of which are highly effective against candida species.The manufacturer have validated this liquid chemical sterilization process with spore forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.In addition, the sterile packaging solution used for shipment of crown valves is a 4% formaldehyde solution; the valves remain in this extremely antimicrobial solution until they are opened during surgery.Therefore, it is not conceivable that a candida could survive on a valve exposed to our sterilant, or the packaging solution based on the site assessment, and based on review of the verification of the device sterilization, the device can be reasonably excluded as a contributory cause of the reported event.The root cause of the endocarditis is attributed to the procedure, per information reported from the site.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8689806
• Report Number: 3004478276-2019-00185
• Device Sequence Number: 14033290
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)210831
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 08/31/2021
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 50