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

Model Number PVS25

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problem Complete Heart Block (2627)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

On (b)(6) 2018, the patient received a perceval pvs25 (size l) as part of his stenotic, aortic valve replacement.After the device deployment in the aortic root, the ballooning was performed.However, the wrong post-dilatation catheter was used (size xl instead of size l).The patient went in heart block and a pacemaker was ultimately implanted.

Manufacturer Narrative

A complete manufacturing and material records review for the nitinol stent component has been performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the information available to date, the root cause of the event is attributable to a procedural error, since the post-dilatation ballooning was performed with an accessory of the wrong size.Device not explanted.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• MDR Report Key: 8007250
• MDR Text Key: 125093091
• Report Number: 3005687633-2018-00204
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)200519
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2020
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 72 YR
• Patient Weight: 56