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

Model Number	CNA23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown disposition.
Event or Problem Description
The manufacturer was informed of this event through the patient tracking department.Based on the information reported in the patient implant form, a crown valve cna23 was implanted on (b)(6) 2019.This valve was explanted on (b)(6) 2021 and replaced with a carbomedics top hat valve s5-025 (this device was explanted on (b)(6) 2021, and reported separately under (b)(4).No further information is presently available.No allegation of a device malfunction nor of a serious injury was indicated during this particular event.
Additional 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 the manufacturer¿s quality engineering.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.The manufacturer attempted to retrieve additional information on the reported event and the device involved.Since no further information was received and the device was not returned after the explant (unknown disposition), no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive conclusion to the reported event.However, per the document review performed, no manufacturing deficiencies were identified for the involved device.The root cause remains undetermined at this time.Should further information be received in the future, a follow up report will be provided.
Event or Problem Description
The manufacturer was informed of this event through the patient tracking department.Based on the information reported in the patient implant form, a crown valve cna23 was implanted on (b)(6) 2019.This valve was explanted on (b)(6) 2021 and replaced with a carbomedics top hat valve s5-025 (this device was ultimately explanted on (b)(6) 2021, ref 3005687633-2021-00131).No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 11894812
• Report Number: 3004478276-2021-00163
• Device Sequence Number: 16471392
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)201231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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: 52 YR