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

Model Number PVS23

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

Patient Problem Heart Failure (2206)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Since the device remains implanted and given that the serial number is unknown, no investigation is possible at this time.Based on the information reported in the paper, it is reported that the perceval displacement may have been attributed to a combination of an initial mis-sizing of the device ('a larger perceval prosthesis would have been more suitable, as for manufacturer indications') and procedural factors ('the implantation technique itself could have favored the valve instability').Furthermore, based on the ct scan findings, the device appeared well expanded and shaped.Ultimately, since no device inspection was possible, the cause cannot be definitively stated.The manufacturer is following up to retrieve additional information on the event and, if received, a follow-up report will be provided.Device not explanted.

Event Description

The manufacturer was informed on this event through the recent publication 'perceval sutureless valve migration treated by valve-in-valve with a corevalve evolut pro' by a.Laricchia et al.The paper reports that a (b)(6) male patient received a perceval pvs23 through right mini-thoracotomy.Postoperatively, the patient progressively developed signs of heart failure and transesophageal echocardiography showed severe aortic regurgitation due to a para-valvular leak (pvl).A subsequent computed tomography (ct) scan revealed that the mechanism involved in pvl was a partial migration of the perceval prosthesis at the level of the noncoronary cusp.Due to the patient's comorbidities, the heart team excluded a second surgery and decided to perform a viv tavr with a corevalve evolut pro 29.The tavr was successfully performed, with trivial residual aortic regurgitation.The patient was discharged on the sixth postoperative day in good general conditions.No adverse events are reported at the 1-month follow-up visit.

Manufacturer Narrative

Since the device remains implanted and given that the serial number is unknown, no investigation is possible at this time.Based on the information reported in the paper, possible contributing factors to the reported event were identified in an initial mis-sizing of the device ('a larger perceval prosthesis would have been more suitable, as for manufacturer indications') and procedural factors ('the implantation technique itself could have favored the valve instability').Ultimately, since no device inspection was possible, the cause cannot be definitively stated.

Event Description

The manufacturer was informed on this event through the recent publication 'perceval sutureless valve migration treated by valve-in-valve with a corevalve evolut pro' by a.Laricchia et al.The paper reports that a 73 years old male patient received a perceval pvs23 through right mini-thoracotomy on (b)(6) 2019.It is reported that the patient progressively developed signs of heart failure and transesophageal echocardiography showed severe aortic regurgitation due to a para-valvular leak (pvl).A subsequent computed tomography (ct) scan revealed that the mechanism involved in pvl was a partial migration of the perceval prosthesis at the level of the noncoronary cusp.Due to the patient's comorbidities, the heart team excluded a second surgery and decided to perform a viv tavr with a corevalve evolut pro 29.The tavr was successfully performed on (b)(6) 2019.The tavr was successfully performed, with trivial residual aortic regurgitation.The patient was discharged on the sixth postoperative day in good general conditions.No adverse events are reported at the 1-month follow-up visit.The paper also reports that the patient developed a third-degree atrioventricular block needing a permanent pacemaker on (b)(6) 2019 (submitted under mw 3004478276-2020-00118).

• 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: 9707185
• MDR Text Key: 179352996
• Report Number: 3004478276-2020-00119
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR