MAUDE Adverse Event Report: LIVANOVA CANADA CORP PERCEVAL S HEART VALVE; TISSUE HEART VALVE

Model Number PVS23

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

The initial malpositioning of the device can be attributed to user error, and may also be related to a failure to follow the instructions for use, given that the guiding sutures were held by a tourniquet which is not indicated in the ifu.The observed paravalvular leak can reasonably be attributed to bulky calcium in the patient annulus which was removed aver re-opening the aortotomy, given that the device was ultimately implanted successfully without any paravalvular leak.The perceval ifu explicitly states that bulky or protruding calcium must be removed prior to implant.Therefore, the failure to remove such calcium is considered a failure to follow the instructions for use.The subsequent dislodgement during the de-airing process can reasonably be attributed to the manipulation of the heart.It is explicitly stated in the instructions for use that care must be taken if manipulation of the heart is required, as this may lead to dislodgement of the valve.Based on the information provided, the device was ultimately implanted successfully.As such, no device issue is suspected.The reported event can reasonably be attribute to user error and a failure to follow the instructions for use, as discussed above.Not explanted.

Event Description

An pvs23 was implanted during an isolated avr.The patient's annulus was decalcified and the valve was sized for a pvs23.The valve was collapsed and parachuted into place.The guiding sutures were held in place using tourniquets, not according to the ifu.The valve was positioned to high, so it was removed and re-collapsed against the ifu.The valve was re-implanted, this time with an assistant holding the guiding sutures.The surgeon ballooned the valve at 3 atm (off-label), and warm saline was applied.The aortotomy was closed and the patient was weaned from bypass.On echo, the placement of the valve was correct.A small paravalvular leak was identified on the non-coronary side where there was previously a large bulk of calcium.After de-airing, the valve migrated into the sinuses and a paravalvular and central leak were observed.The heart was reportedly manipulated during the de-airing process which could have led to the observed dislodgement.Cardiopulmonary bypass was resumed and the aortotomy was re-opened.Visual inspection confirmed that the valve was too high, as indicated by echo.The valve was once again removed, and further decalcification was performed where the initial paravalvular leak was identified.The valve was re-collapsed and re-implanted, with an assistant holding the guiding sutures.Visual inspection confirmed the appropriate placement of the valve, and good coaptation.The vale was ballooned for 30 seconds at 4 atm, and warm saline was applied.The aortotomy was closed, and the patient was weaned from bypass.Echo confirmed appropriate valve placement, and no leaks were identified.The mean gradient was 5 mmhg.The first and second cross-clamp times were 84 minutes and 60 minutes, respectively.The patient is doing well, with good sinus rhythm and function post-operatively.

• Brand Name: PERCEVAL S HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 7727935
• MDR Text Key: 115277539
• Report Number: 3004478276-2018-00265
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)201116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• 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
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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): Required Intervention
• Patient Age: 84 YR