MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET LAA OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Patient Problem Perforation (2001)

Event Date 08/03/2023

Event Type  Injury  

Event Description

Amulet device placed in atrial appendage, deployed well, appropriately sized and well seated.Echo normal following procedure.Approximately 3 hours later, patient suddenly decompensated, was taken to the or and found to have a hole in his pulmonary artery caused by puncture from the amulet device.Upon completion of device placement: ef of 60-65% by visual estimation; no evidence of pericardial effusion following procedure.

• Brand Name: AMPLATZER AMULET LAA OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17585234
• MDR Text Key: 321721465
• Report Number: MW5144779
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White