MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS25

Device Problem Perivalvular Leak (1457)

Patient Problems Failure of Implant (1924); Regurgitation, Valvular (2335)

Event Date 04/14/2016

Event Type  Injury  

Event Description

The manufacturer was notified on (b)(6) 2016 that during the implant, surgeon performed cags x3 and avr (pvs25).Came of bypass and aortic valve had moderate central regurgitation.Patient was put back on bypass.Surgeon felt valve was well seated.The perceval valve was explanted and a magna ease size 21 was implanted.The patient has a pre-op peak gradient of 134: tbt 226; xct 179.First x-clamptime: 84 (avr & cagsx2).Second x-clamptime: 95 (removed perceval and magna e implanted).Patient outcomes: patient was taken back to theatre 0500 the next morning, no oozing.Inr 2.0 treated with novoseven f7a.Vascath inserted for acute renal failure.Dialysis (patient had a code blue during dialysis).Ph 7.09.Gastric bleed 3/5/16 (hb 4.0).

Manufacturer Narrative

The complete manufacturing and material records for the perceval s aortic heart valve, model icv1210, s/n (b)(4), were pulled and reviewed to confirm that this valve satisfied all material, visual, and performance standards required for a perceval s valve at the time of manufacture and release.The visual inspections performed on the returned prosthesis confirmed the absence of manufacturing defects.The hydrodynamic testing conducted on the perceval size 25/l heart valve prosthesis sn (b)(4) did not reveal any anomalies during the open/close phases as the valve demonstrated the correct leaflets coaptation and showed a regurgitant fraction in line with iso 5840 requirements.As a magna ease size 21 valve was implanted instead of the perceval size 25 valve, the central leak can be due to the use of an oversized valve.As a result, this could lead to an excess of pericardial tissue that could prevent the proper leaflet coaptation detected.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby,
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125696
• MDR Report Key: 5658547
• MDR Text Key: 45277280
• Report Number: 3004478276-2016-00049
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2017

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: Other
• Device Expiration Date: 09/22/2018
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/21/2016; 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0716-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention