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

Model Number	CNA21
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
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 livanova (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.As the device has not yet been explanted, no further investigation can be performed at this time.The manufacturer is presently following up to retrieve additional information, and a supplemental report will be submitted should further information be received.At this time, the root cause of this early degeneration cannot be established.
Event or Problem Description
On (b)(6) 2018, a patient underwent an aortic valve replacement.The operative diagnosis was of aortic valve stenosis (aortic valve heavily calcified).The received a cna21 in aortic position.The procedure was completed uneventfully.The manufacturer was informed that the device went into early degeneration.An echo was performed on (b)(6) 2020, where it was confirmed that the prosthesis appeared calcified with systolic gradients mean/max of 80 mmhg/120 mmhg.It was confirmed that the patient requires a re-intervention.
Additional Manufacturer Narrative
Since the device was not yet explanted, no further investigation can be performed at this time and a definitive root cause for this early degeneration cannot be established.It should be noted that structural valve deterioration is listed as a possible adverse event in the crown ifu.The event is, therefore, a known inherent risk of the device.It is possible that the patient's clinical history and risk factors contributed to the reported event.However, since no additional information on this regards has been provided, this cannot be ultimately confirmed.Should further information be provided, an update to this reporting activity will be provided.

• 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: 10618165
• Report Number: 3004478276-2020-00199
• Device Sequence Number: 14364789
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)221231
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 12/31/2022
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: Other
• Patient Age: 65 YR