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

Model Number	CNA19
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the cna19 crown valve was implanted supra annular by midline incision.The concomitant procedure was tricuspid annuloplasty.After de-clamping, the device functionality was checked by the echo and central leakage was detected.They re-clamped and performed additional stitches using the suture with felt, but it was not successful.Ultimately, the device was explanted and inspiris 19 mm was implanted instead with no issue.Based on the information received, there was no impact on the patient.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, s/n # (b)(4), 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.A review of the function test (open/close valve) at the time of manufacture and release was also performed.Video showed synchronous opening and closing with smooth, continuous motion and no leaflet fluttering.Meets all function test criteria observable on video for a size 19 model cn.Based on video playback and review for this, the above valve performed as expected and met applicable function test quality control criteria as outlined in dedicated procedure.The device is returned to the manufacturer and the investigation is on going.The follow up will be provided upon the completion of the investigation.
Additional Manufacturer Narrative
The cna19 was returned to the manufacturer.A preliminary visual inspection was performed in order to record the gross appearance of the returned valve in its ¿as received¿ conditions.After decontamination, the valve was visually inspected without highlighting elements of non-conformity, according to the specifications.The returned cna19 resulted in compliance with the specification required at the time of manufacture and release.Based on the review of the functional tests and given the result of the visual inspection, no further investigation is deemed necessary at this time.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defects or elements of non-conformity.Furthermore, no deficiencies were identified during the reviews of the production records and functional test inspection.Should further information be received in the future, the manufacturer will provide a follow up report.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CROP.; corcym canada corp.; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13690870
• Report Number: 3004478276-2022-00131
• Device Sequence Number: 17376058
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)240331
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 03/31/2024
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 42 KG