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

Model Number CNA23

Device Problem Calcified (1077)

Patient Problem No Information (3190)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Discarded by the site.

Event Description

A crown valve cna23 was implanted in 2018, became calcified, then explanted on (b)(6) 2020 and replaced with a mechanical prosthesis.No further information is available at this time.

Manufacturer Narrative

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.

Manufacturer Narrative

Updated sections b4, d3, g1, g3, g6, h1, h2 (completed as a placeholder, no new information received),h3, h6 (corrected coding) based on the information available, it is not possible to draw a definitive conclusion for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.As reported in the scientific literature, structural valve deterioration is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this crown valve.However, little clinical history was provided and a definitive root cause cannot be stated at this time.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.Since the device was discarded, no further investigation is possible at this time.The manufacturer attempted to retrieve additional information on the event but no further information was received to date.Should further information be provided in the future, an update to this reporting activity will be provided.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 10752944
• MDR Text Key: 213694946
• Report Number: 3004478276-2020-00223
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)220531
• Combination Product (y/n): N
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 09/28/2021
• Supplement Dates FDA Received: 12/04/2020; 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR