MAUDE Adverse Event Report: ST JUDE MEDICAL, INC./ABBOTT LABORATORIES ST JUDE AMPLATZER; TRANSCATHETER SEPTAL OCCLUDER

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 12/01/2017

Event Type  Injury  

Event Description

I had a pfo closure procedure on (b)(6) 2017 with the st jude amplatzer device.On (b)(6) 2017, just prior to being discharged from the hospital, i suffered severe cardiac erosion and cardiac tamponade.The device perforated 2 holes in my heart that required 2 emergency open heart surgeries.I spent 4-5 days in cardiac intensive care and additional days in the hospital to recover.The device is still in my heart.

• Brand Name: ST JUDE AMPLATZER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST JUDE MEDICAL, INC./ABBOTT LABORATORIES
• MDR Report Key: 8124755
• MDR Text Key: 129313936
• Report Number: MW5081763
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 56