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 Valve Insufficiency/ Regurgitation (4450)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

Although the regurgitation was attributed to the presence of calcifications that seems to push the stent (patient's factors) the event is being notified due to unknown impact on patient for intraoperative explant.Furthermore, from the information reported, it appears that the perceval valve was re-implanted after the intraoperative explant.Per the perceval valve ifu ''a removed perceval s prosthesis must not be reimplanted, because its integrity is no longer ensured.''.Thus, the decision to re-implant the same prosthesis was made off-label.The manufacturer is performing further investigation and will update this reporting activity based on additional information received.

Event Description

The patient underwent a re-do avr procedure on (b)(6) 2021, where a crown cna19 was explanted (submitted separately under livanova ref (b)(4)) and a perceval valve pvs21 was implanted.A midline incision was performed to remove the crown valve and surrounding atheroma (plaque) and myxoma.The circumference of the annulus was trimmed and sized to select the perceval valve.After the implant, the echocardiogram showed regurgitation around the valve from the rcc (mild> trivial) and from ncc (trivial), so the cross clamp was restarted.The implant position of perceval valve appeared acceptable, but the calcification adhering to the vicinity of the annulus from the left coronary artery seemed to push the stent, so the device was re-implanted was repeated again.Before re-implanting the valve, decalcification was performed again and the size was confirmed.At the time of confirmation by the subsequent echo, the regurgitation around the valve was small, but the trivial regurgitation was confirmed on the rcc side.Since there was little reflux, weaning was attempted, but cardiac function did not improve and iabp was placed.Echo confirmation after the start of iabp showed that rcc regurgitation increased from trivial to mild.The regurgitation remained from the part where the hardness of the annulus was different but it could not be confirmed the reason why the regurgitation remained.Since it was expected that iabp would be used in combination after withdrawal from extracorporeal circulation, perceval valve was removed and a mosaic valve 19 mm was implanted instead during the same day (b)(6) 2021.The additional extracorporeal circulation time: 2 hours 12 minutes.The additional cross clamp time: 1 hour 28 minutes.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 11898699
• MDR Text Key: 255617173
• Report Number: 1718850-2021-01091
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230422
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2021,05/27/2021

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: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2021
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 59