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

Model Number	CNA23
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna23, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4).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 document review performed, no manufacturing deficiencies were identified.However, as the device was not explanted and the patient's clinical history and risk factors are unknown, no further investigation can be performed and the root cause of the event cannot be determined.Not explanted.
Event or Problem Description
A crown cna23 was implanted on (b)(6) 2015, and concomitant cabgx3 was performed.The mean gradient at discharge and at follow up on (b)(6) 2017 were 10 mmhg and 13.7 mmhg, respectively.The patient was admitted to the hospital in (b)(6) 2018 with decompensated heart failure requiring iv diuresis and inotropes.Echocardiography on (b)(6) 2018 showed a mean gradient of 27 mmhg with moderate ar.The valve was well seated with calcified cusps and reduced excursion.On (b)(6) 2018, the patient underwent urgent tavi due to structural valve deterioration.

• 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: 7567805
• Report Number: 3004478276-2018-00209
• Device Sequence Number: 13956271
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)191031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: 10/31/2019
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/04/2018
• 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: 58 YR