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  

Manufacturer Narrative

Device not explanted.

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) 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.

Manufacturer Narrative

The manufacturer received the serial number of the device involved in this event.

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.

Manufacturer Narrative

Sections changed: b3, b4, b5, d6, g4, g7, h1, h2, h6.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since the device was not explanted (viv performed), no further device investigation is possible at this time.Based on the available information, and given that no analysis of the device could be performed, it is not possible to draw a definitive conclusion for the reported event.However, based on the document review performed no manufacturing deficits were identified.As commented in the paper, 'although the surgeon was familiarized with the surgical technique, we cannot assure whether or not the cause of the dislocation could be related to the valve undersizing or to a high positioning of the prosthesis'.Based on this, a possible root cause can be traced to an unintended procedural error (malpositioning/mis-sizing).

• 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: 9211730
• MDR Text Key: 163128127
• Report Number: 3005687633-2019-00236
• 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: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR