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

Model Number	CNA21
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received for investigation on july 23, 2018.Gross examination confirmed that the returned prosthesis is in generally good condition.Investigation is ongoing.
Event or Problem Description
When weaning from bypass after mitroflow valve implant, central leak was identified via tee.The right coronary leaflet seemed to be stiff and did not coapt during diastole.Cpb was resumed, and the valve was examined.No defects were identified, and nothing was identified that might be interfering with the leaflet's mobility.The valve was explanted and replaced with another mitroflow valve of the same size.The patient was weaned from bypass, and the patient recovered without incident.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model#: cna21, s/n#: (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at (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.Review of the function test video for the device confirmed that the valve performed as expected and met applicable function test quality control criteria as outlined in 450-08ip002 rev aa prior to release.No anomalous behavior was identified during the open/close cycles that could contribute to the reported event.Visual inspection of the returned device was performed.No elements of non-conformity were identified.Hydrodynamic testing was performed on the returned device, and confirmed that the valve meets iso 5840 minimum requirements.No anomalies were identified during the open/close motion.The regurgitant fraction was well below iso 5840 requirements.Based on the performed analysis, the device can reasonably be excluded as a contributing factor in the reported event.The event cannot be explained by any factor intrinsic to the involved device.

• 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 V5J5M 1; CA V5J5M1
• MDR Report Key: 7744635
• Report Number: 3004478276-2018-00269
• Device Sequence Number: 19210146
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)211113
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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: Health Professional
• Device Expiration Date: 11/13/2021
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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
• Patient Age: 76 YR
• Patient Weight: 65