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

Model Number PVS21

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

As the serial number of this device is unknown, the manufacturer may be livanova canada corp (as indicated in this report) or sorin group italita, s.R.L.The manufacturer information will be updated if the serial number is obtained.Device not available for return.

Event Description

A size 21 perceval valve was implanted in (b)(6) 2017.The valve has been reported to have migrated, and will require re-operation.A tavi was planned for (b)(6) 2017, as the patient is no longer a candidate for open heart surgery.

Manufacturer Narrative

The manufacturer followed up multiple times to determine the serial number of this device without success.Since the device was not explanted (viv procedure was performed) and the serial number was not provided, no investigation could be performed.Based on the information received from the hospital, the valve appeared to be mispositioned after the implant.It is possible that the initial malpositioning of the perceval valve might have lead to a valve migration.

Event Description

Based on the update received: at the time of implant the perceval valve was malpositioned.On (b)(6) 2017 a valve in valve procedure has been performed and the es size 23 was implanted in the perceval valve.The patient had a good recovery.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7088838
• MDR Text Key: 94094660
• Report Number: 3004478276-2017-00199
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR