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

Model Number PVS25

Device Problems Perivalvular Leak (1457); Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Insufficiency (1715)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Based on the available information, there is not enough evidence to suspect that the perivalvular leak detected was a result of a device dysfunction.In fact, the same device was re-collapsed and re-implanted in the patient, and a good device functionality was detected at the echo postoperatively.Therefore, the initial perivalvular leak can be reasonably considered a result of procedural error.For this reason, and since the device remains implanted int he patient, no further investigation is warranted at this time.It should be noted that the perceval ifu contains the following warning: 'a removed perceval prosthesis must not be re-implanted, because its integrity is no longer ensured'.As such, the decision to re-implant the same valve was made off-label.With regards to the patient's tia, there is no evidence of device dysfunction that could have given rise to a thromboembolic event, or otherwise contributed to the reported tia.Tia is a known inherent risk of cardiopulmonary bypass, thus it is possible that the prolonged surgical time (pump time: 110 min) contributed to the reported event.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2019, a pvs25 implant attempt occurred.Per the information reported on the registry, the first implant attempt was not successful due to sizing difficulties.The toe showed a significant paravalvular leak, and the valve was reportedly removed and re-expanded.The procedure was performed in mini-sternotomy and no concomitant procedures were performed.The procedural times were the following: 110min pump time and 68 min cross-clamp time.The manufacturer was informed that the patient experienced an ischemic tia on postoperative day 3 ((b)(6) 2019).The device functionality was checked on the same day and good functionality is reported (13mmhg, no central/perivalvular leaks).The patient was discharged to home on (b)(6) 2019.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2019, a pvs25 implant attempt occurred.As reported from the field, the valve was initially implanted and all appeared to progress as normal.However, after the aortic clamp was removed and the patient weaned off the cardiopulmonary bypass it was clear that there was a mild to moderate leak at the non-coronary side of the valve.The cross-clamp was re-applied and on opening the aorta it appeared that the valve had migrated so the skirt was above the non-coronary annulus.The valve was explanted, the annulus was re-sized and the same valve was implanted successfully.Postoperative and discharge echoes were reportedly satisfactory.The procedure was performed in mini-sternotomy and no concomitant procedures were performed.The procedural times were the following: 110min pump time and 68 min cross-clamp time.The manufacturer was informed that the patient experienced an ischemic tia on postoperative day 3 (b)(6) 2019.The device functionality was checked on the same day and good functionality is reported (13mmhg, no central/perivalvular leaks).The patient was discharged to home on (b)(6) 2019.

Manufacturer Narrative

Fields updated: b4, g4, g7, h1, h2, h6.The manufacturer received additional information on this event, which was included in b5.As reported, the initial perivalvular leak was attributed to an intraoperative dislocation of the device, which was then explanted and re-implanted with no further adverse consequences reported.No further feedback regarding the patient's tia was provided.The additional information provided does not change the root cause analysis previously submitted.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9508091
• MDR Text Key: 178792074
• Report Number: 3004478276-2019-00338
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)220819
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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: 08/19/2022
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/12/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 61