MAUDE Adverse Event Report: LIVANOVA USA, INC. LIVANOVA ; HEART-VALVE, NON ALLOGRAFT TISSUE

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457)

Patient Problems Congestive Heart Failure (1783); Obstruction/Occlusion (2422)

Event Date 12/14/2019

Event Type  Injury  

Event Description

Livanova perceval valve was implanted - 18 months prior to presentation.The valve had migrated distally, causing severe perivalvular leak, congestive heart failure, and obstruction of the right coronary artery.Did not appear to be under or over sized.The pt required redo sternotomy and valve explant, replacement with 27 mm edwards magna ease valve.Fda safety report id# (b)(4).

• Brand Name: LIVANOVA
• Type of Device: HEART-VALVE, NON ALLOGRAFT TISSUE
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 9539120
• MDR Text Key: 173513494
• Report Number: MW5091968
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 70 YR
• Patient Weight: 126