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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

Event Description

On (b)(6) 2021, a patient had a rvao + cabg and a perceval pvs21 was implanted.In the or, the transesophageal echocardiogram (tee) confirmed that the valve was successfully implanted.No leak was identified and the valve appeared functional.In the icu, one or two days post-surgery, a tee was performed and no leak was identified, the valve appeared functional.However, three days after the surgery, the patient was breathless.A tee was performed and an important paravalvular leak was identified.The patient underwent a re-operation on (b)(6) 2021.The valve was explanted and was replaced with a stented valve.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # a93001, as they pertain to the reported event, were retrieved and reviewed by the manufacturer's quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Further investigation is ongoing.

Manufacturer Narrative

The manufacturer received additional information as included in b5.Since the device was reportedly not available for return, no further investigation is possible at this time.Based on the available information, the root cause of the reported postoperative perivalvular leak was attributed to a device dislodgement.Based on the manufacturer's clinical experience of events of dislodgments and given the relative dimensions of the magna ease valve 19 and the perceval pvs21, a possible root cause could be traced to a slight oversizing of the perceval valve.Ultimately, since no further information was provided and no investigation on the device was possible, the root cause of the perceval valve dislodgment cannot be determined at this time.

Event Description

On (b)(6) 2021, a patient had an aortic valve replacement (avr) + cabg and a perceval pvs21 was implanted.In the or, the transesophageal echocardiogram (tee) confirmed that the valve was successfully implanted.No leak was identified and the valve appeared functional.In the icu, one or two days post-surgery, a tee was performed and no leak was identified, the valve appeared functional.However, three days after the surgery, the patient was breathless.A tee was performed and an important paravalvular leak was identified.The patient underwent a re-operation on (b)(6) 2021.The valve was explanted and was replaced with a stented valve.Per additional information received, the patient had a good outcome.The root cause of the perivalvular leak was attributed to a valve dislodgment (as reported, the valve ''moved up'').The perceval valve pvs21 was replaced by a magna ease size 19.No further information nor medical judgment was provided on this case.

• 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: 11897035
• MDR Text Key: 266487773
• Report Number: 3004478276-2021-00164
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)231122
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2021

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: 11/22/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/16/2021; 07/19/2021
• Supplement Dates FDA Received: 07/16/2021; 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR