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

Model Number	CNA19
Medical Device Problem Codes	Gradient Increase (1270); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not explanted.
Event or Problem Description
A crown prt 19 mm valve was implanted on (b)(6) 2018.It was reported that during surgery one leaflet of the valve appeared rigid and was not closing properly.The physician forced the leaflet closed manually, but there was a gap between the leaflets.The physician did not explant the valve and closed the aorta.Post-procedure tee showed no regurgitation and the mean gradient was 15 mmhg (max 25 mmhg).However, at discharge, the patient's gradient was 35 mmhg.The patient is being monitored, but there is a chance that the device will be explanted and replaced.
Event or Problem Description
A crown prt 19 mm valve was implanted on (b)(6) 2018.It was reported that during surgery one leaflet of the valve appeared rigid and was not closing properly.The physician forced the leaflet closed manually, but there was a gap between the leaflets.The physician did not explant the valve and closed the aorta.Post-procedure tee showed no regurgitation and the mean gradient was 15 mmhg (max 25 mmhg).However, at discharge, the patient's gradient was 35 mmhg.The patient is being monitored, but there is a chance that the device will be explanted and replaced if there are future complications or the gradient does not come down.Imaging of the valve was not available for analysis.
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 quality engineering at (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.The function test video from the time of release was reviewed in real time and frame-by-frame.Based on video playback, the valve performed as expected and met applicable function test quality control criteria at the time of release.As imaging of the valve was not available for review and the device remains implanted, no further device investigation can be performed and the root cause of the event cannot be determined.However, based on the document review performed, no manufacturing deficiencies have been identified.

• 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: 8103982
• Report Number: 3004478276-2018-00347
• Device Sequence Number: 13886730
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)230531
• 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): 12/14/2018

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: CNA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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: 57 YR