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 Problems Aortic Insufficiency (1715); Heart Failure (2206)

Event Date 12/09/2016

Event Type  Injury  

Event Description

The manufacturer was informed on this event through the recent publication 'acute dislocation of a perceval valve treated with tavi valve-in-valve: a literature review and case report' by julieta d morales-portano et al.A (b)(6)-year-old male with a history of hypertension, presented with severe dyspnea (nyha-iii); severe aortic stenosis was revealed by transthoracic echocardiography (tte); surgical procedure with a perceval valve size m (pvs23) was made without any complications (mean gradient 12 mmhg.The patient was transferred to the intensive care unit, but twenty-four hours after the procedure, the patient presented acute heart failure.The tee revealed a severe paravalvular leak, then fluoroscopy confirmed the dislocated and dysfunctional perceval valve.An emergency transcatheter aortic valve-in-valve (tavi-viv) procedure with a corevalve 29 mm was performed to correct the dislocated valve.The clinical status of the patient improved rapidly, and the patient was discharged without any complications one week after the procedure.

Event Description

The implant of the perceval was on (b)(6) 2016, and the date of tavi was (b)(6) 2016.The remainder of the information previously submitted remains unchanged.

• 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: 9211727
• MDR Text Key: 174598153
• Report Number: 1718850-2019-01129
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2019,02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2019
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2019
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR