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

Model Number PVS21

Device Problem Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, perceval (serial# (b)(4)) was indwelled through a midline incision and coronary artery bypass grafting (triple bypass, svg/ao-om-pl, lita-d1) was performed.Because the patient was a small build and the arch of aorta was short, the aorta was incised around 25 mm from the valve.Surgery was performed from cabg, valve sizing was performed, and size s was selected prior to anastomosis to the central side.The transparent side of the size s sizer passed easily through the annulus, and the white side of the size s sizer passed at last with pushing.The 20mm bougie sizer did not pass through the annulus.After removing the calcification site, the perforated part of the annulus was repaired by z-suturing.Perceval was implanted without sizing again.The surgeon judged that there was no problem with visual confirmation, and the implantation was finished.A transesophageal echocardiogram was performed, but it was difficult to identify the image, so an echo was performed with the direct probe of the aorta after the pump was turned off.Echo showed a moderate perivalvular leakage and central leakage from non-coronary cusp.Cpb and x-clamp was performed again and the valve was confirmed, then stent folding was confirmed on the ncc side.Perceval was removed and crown / prt size 19mm was implanted.1st x-clamp time was 146 minutes, 1st cpb time was 195 minutes.2nd x-clamp time was 68 minutes, 2nd cpb time was 95 minutes.

Manufacturer Narrative

The manufacturer is submitting a late notification of the date the device was returned.The device was returned on dec.23, 2019.The manufacturer is concluding it investigations and will update the competent authority regarding the valve investigations and device history record review results.

Manufacturer Narrative

Review of the data filed in the device history record confirmed that the returned perceval heart valve sn (b)(6) , satisfied all material, dimensional, and performance standards required for a perceval valve 21/s at the time of manufacture and release.After decontamination, a visual inspection of the valve was performed according to the procedure 850-08ip200 (current revision at the time of manufacture and release).Photographs of the device were taken during this step.The returned pvs 21/s was received in the styrofoam box, contained in the original plastic jar, and appeared in general good conditions.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.The manufacturer is currently following up with the site to obtain further event information to clarify the underlying root cause of the reported stent folding and will update the competent authority if further information is received.

• 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
• MDR Report Key: 9469815
• MDR Text Key: 176230254
• Report Number: 1718850-2019-01207
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)220131
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019,02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2019
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2019
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 40