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

Model Number CNA

Device Problems Bent (1059); Difficult to Fold, Unfold or Collapse (1254); Insufficient Information (3190)

Patient Problem Aortic Insufficiency (1715)

Event Date 04/27/2016

Event Type  Death  

Manufacturer Narrative

Livanova followed up to obtain more information on the device, details about the surgery and return of the device.It was indicated during the follow up that device will not be returned and no analysis report is expected.Due to the fact that no information about the serial number of the device and device is not going to be returned for analysis, it is not possible to perform device history record review and any investigation of the reported event.

Event Description

The manufacturer was notified on 29 april 2016 that a crown valve implanted on (b)(6) 2016 showed steno- insufficiency with high gradient.The valve was then explanted.No further information was provided.

Manufacturer Narrative

Narrative: the complete manufacturing and material records for the crown prt aortic pericardial heart valve, cna23(sn# (b)(4)), were pulled and reviewed by quality control at livanova (b)(4) corp.The results confirmed that each manufacturing and inspection operations were followed and 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.Pre-shipment function test video was reviewed to qualitatively evaluate valve in 4 phases: closed, opening, open and closing.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 23 model cna.The valve performed as expected and met all function test quality control criteria that can be observed during video playback.No stent deformation was observed in the review of the record at the time of release of the crown prt valve.Corrections: outcomes attributed to adverse events, type of reportable events, date received by mfr, evaluation codes, sex.Additional information: device not returned.

Event Description

Additional information: on july 15, 2016, manufacturer was notified that the crown valve did not open properly and stent seems not to be straight anymore after the implantation and was curved to the middle.Crown valve was explanted.Patient was implanted with perimount valve.Afterwards, patient had a myocardial infarction and patient died.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1 ; 4125696
• MDR Report Key: 5685896
• MDR Text Key: 46122996
• Report Number: 3004478276-2016-00058
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060038/S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2021
• Device Model Number: CNA
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention